Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section technology · Version 2026-09-01 · Cadence annual · Evidence class mixed · Sources 13 · Supersedes none
Domain: pediatric-persistent-asthma-home-monitoring · Scope: public primary sources via connectors, WebSearch and WebFetch
Sourcing: openFDA 510(k)/classification/recall registry pulls for two accessory-hardware product codes (CAF, MXA) and three US ClinicalTrials.gov protocol records, plus two PubMed narrative reviews and one PubMed comparative-validation study
The domain dossier's own technology section (§7) is derived entirely from the spirometer/peak-flow clearance sweep already used for reference products; this report looks at the two hardware categories that sit alongside spirometry rather than duplicating it. Since the first Bluetooth medication-adherence sensor cleared in 2015, FDA has cleared a growing run of clip-on inhaler/nebulizer sensors under one shared product code, and a separate, smaller run of handheld point-of-care fractional exhaled nitric oxide (FeNO) testers under a second product code — both retrofit accessories that attach to an existing prescribed inhaler or replace a lab-only breath test, rather than new classes of primary hardware. A parallel research literature is starting to describe forced oscillation technique (FOT) and multiple-breath nitrogen washout as lung-function tests that are newly feasible in "less cooperative" subjects, including at home, though this report found no US pediatric home-FOT device clearance to attach that trend to. Three US ClinicalTrials.gov protocol records show pediatric-persistent-asthma-specific pilots of this hardware are actively being registered, but none has posted results.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
A 2025 review of digital health in pediatric asthma names this category by its common commercial labels — "wearable devices, smart inhaler, digihaler, smart spacer, smart nebulizer, adherence monitoring, home spirometry, and symptom monitoring" — as the set of technologies it searched the literature for, without itself quantifying how many cleared devices exist under any one of those labels [1] [single-source]. FDA's product code CAF ("Nebulizer, Direct Patient Interface," 21 CFR 868.5630, Class 2) covers compressor/mesh nebulizers, spacers, and — filed under the same code because they attach to an existing inhaler rather than delivering the drug themselves — clip-on adherence sensors. A clearances sweep of this code returned 59 total 510(k)s decided 2016-09-05 through 2026-09-03, of which the connector returned the 50 most recent as a floor, not a complete count [4]. Reading that list, at least 14 of the 50 are sensor-only devices rather than nebulizers or spacers: the Hailie Sensor family from Adherium (NZ) Ltd. (K181405, K182573, K182638, K220622, K221994, K222247, K211233 — seven separate clearances 2018–2023, one per inhaler-form-factor variant), Adherium's earlier Smartinhaler (K180407) and SmartTouch (K173310), the Ochsner Connected Inhaler Sensor (K223367, 2023), Voluntis's HeroTracker Sense (K250022, 2025), Cognita Labs' CapMedic (K183586), and BreatheSuite's MDI V1 (K203155) [4]. The category's origin point, found by a separate direct 510(k) lookup rather than the windowed sweep, is Reciprocal Labs Corporation's Propeller System, cleared 2015-05-15 — one year before this report's ten-year window opens — with two follow-on device-specific Propeller sensors (K180770 for Neohaler, K192724 for Symbicort) cleared inside the window [6]. None of the 18 CAF-code recalls in the same ten-year window name a sensor device by product name; all 18 concern nebulizer, spacer, or saline-vial defects (sterility, labeling, particle sizing) [7].
A separate, smaller product code, MXA ("System, Test, Breath Nitric Oxide," 21 CFR 862.3080, Class 2), covers portable point-of-care FeNO analyzers. Seven devices cleared in this code across the same ten-year window: NIOX VERO (K170983, 2017), Fenom Pro (K182874, 2019, later re-cleared as K213611 under Caire Diagnostics in 2023), NObreath (K203695, 2021), Bosch's Vivatmo pro (K233775,
of these seven carries a recall: Z-1284-2021, initiated 2021-02-26 against the Fenom Pro (K182874), reason given as "erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment," attributed to calibration-gas drift and a software error [10]. That recall reason is the clearest documented failure mode this report found for any device category in this dossier's technology space — not a hardware or adherence failure but a measurement-accuracy failure with a stated downstream clinical consequence. A single comparative validation study of a different handheld FeNO device (Bosch's Vivatmo Me) against a NIOX VERO reference, in 164 adult patients (not pediatric), found the two devices "highly correlated" but with a statistically significant mean difference (P<.001), and reported that 32% of Vivatmo Me readings fell outside the device's own claimed accuracy range before a linear correction was applied [3] [single-source]. No pediatric-specific home-FeNO accuracy study was located.
A 2025 narrative review states that "FOT, in particular, facilitates measurement acceptability in less cooperative subjects, both in respiratory physiology labs and even at the patient's home," naming FOT and multiple-breath nitrogen washout (MBNW) alongside spirometry as newer pediatric lung-function tools [2] [single-source]. This is a single review's framing of a trend, not a device-level finding, and this report located no FDA 510(k) clearance or US pediatric trial specifically testing a home FOT or MBNW device — the dossier's own reference-products section already covers spirometry (BZG) and peak-flow (BZH) clearances, and this report's own classification and 510(k) queries for "nitric oxide analyzer" and "breath analyzer" device names returned no additional matching product code beyond MXA above.
Three ClinicalTrials.gov protocol records name pediatric persistent-asthma populations directly and test the hardware categories above, none with posted results — the same "sponsor's intention, not a finding" caveat the domain dossier already applies to its own §5 trial records. Connecticut Children's Medical Center registered NCT03648450, an observational feasibility/ acceptability study of the Propeller electronic medication monitor in 50 (ACTUAL) children aged 10–18 with a "history of persistent asthma (defined as prescribed a controller medication)," status COMPLETED, hasResults=false [11] [single-source · sponsor-reported]. Boston Children's Hospital registered NCT06825871, a single-group interventional pilot of the "aflo™" digital inhaler-technique platform in 20 (ACTUAL) participants aged 10 and up with physician-diagnosed persistent asthma and FEV1/FVC <80%, status COMPLETED, hasResults=false [12] [single-source · sponsor-reported]. Children's Hospital Los Angeles registered NCT06783101, a randomized feasibility/acceptability/usability trial of an unnamed "smart inhaler" in 30 (ESTIMATED) adolescents aged 10–17 with moderate-to-severe asthma and a co-occurring intellectual/developmental disability diagnosis, status RECRUITING [13] [single-source · sponsor-reported]. Read together with §5's ALPACA/Cornell findings, this dossier now has five identified US or industry-sponsored pediatric home-monitoring hardware pilots on ClinicalTrials.gov, and none of the five has posted an outcome.
[1] "Use of Digital Health in Pediatric Asthma" — Respiratory Care (published 2025-06, day not given in the PubMed record; accessed 2026-09-01). PMID 40045921 — https://pubmed.ncbi.nlm.nih.gov/40045921/ [peer-reviewed] [2] "Lung Function Assessment in Pediatric Asthma: Selecting the Optimal Tests for Clinical and Research Applications" — Children (Basel) (published 2025-08-15; accessed 2026-09-01). PMID 40868524 — https://pubmed.ncbi.nlm.nih.gov/40868524/ [peer-reviewed] [3] "Comparative validation of handheld fractional exhaled nitric oxide measurements" — Expert Review of Medical Devices (published 2025, month not given in the PubMed record; accessed 2026-09-01). PMID 40289685 — https://pubmed.ncbi.nlm.nih.gov/40289685/ [peer-reviewed] [4] openFDA device/510(k) clearances, product_code=CAF, decided 2016-09-05 to 2026-09-03, 59 total matches, 50 shown (published continuously; accessed 2026-09-01). K222247 among others — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222247 [federal-registry] [5] openFDA device/classification product_code=CAF, "Nebulizer (Direct Patient Interface)" (published continuously; accessed 2026-09-01). 21 CFR 868.5630 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm [federal-registry] [6] openFDA device/510(k) single-record lookup, "Propeller System," Reciprocal Labs Corporation, decided 2015-05-15 (published 2015-05-15; accessed 2026-09-01). K142516 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142516 [federal-registry] [7] openFDA device/recall, product_code=CAF, initiated 2016-09-05 to 2026-09-03, 18 records (published continuously; accessed 2026-09-01). Z-2514-2023 among others — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [8] openFDA device/classification product_code=MXA, "System, Test, Breath Nitric Oxide" (published continuously; accessed 2026-09-01). 21 CFR 862.3080 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm [federal-registry] [9] openFDA device/510(k) clearances, product_code=MXA, decided 2016-09-05 to 2026-09-03, 7 total matches (published continuously; accessed 2026-09-01). K170983 among others — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170983 [federal-registry] [10] openFDA device/recall Z-1284-2021, Caire Diagnostics Inc., Fenom Pro (published 2021-02-26; accessed 2026-09-01). Z-1284-2021, related 510(k) K182874 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [11] ClinicalTrials.gov NCT03648450 — "Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma," Connecticut Children's Medical Center (record status updated 2023-09-18; accessed 2026-09-01). NCT03648450 — https://clinicaltrials.gov/study/NCT03648450 [trial-registry] [12] ClinicalTrials.gov NCT06825871 — "Automated Inhaler Monitoring for Asthma Medication Usage," Boston Children's Hospital (record status updated 2026-07-29; accessed 2026-09-01). NCT06825871 — https://clinicaltrials.gov/study/NCT06825871 [trial-registry] [13] ClinicalTrials.gov NCT06783101 — "Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities," Children's Hospital Los Angeles (record status updated 2025-01-20; accessed 2026-09-01). NCT06783101 — https://clinicaltrials.gov/study/NCT06783101 [trial-registry]
Well established: The existence and count of two distinct FDA product codes for retrofit/accessory hardware — CAF (inhaler/nebulizer accessories, including clip-on adherence sensors) and MXA (portable FeNO testers) — rests directly on openFDA registry pulls [4][5][8][9] and is stated plainly. The Fenom Pro accuracy recall [10] is a single registry record, stated plainly because it is the primary record itself, not a secondary account of it. The three pediatric-persistent-asthma trial registrations [11][12][13] are each a single ClinicalTrials.gov record and are marked [single-source · sponsor-reported] where their content is the sponsor's own planned outcomes rather than a finding.
Thin: The Vivatmo Me vs. NIOX VERO accuracy comparison [3] rests on one study, in adults, not children, and is marked [single-source] for that reason as well as for count. The FOT/MBNW "newly possible at home" framing [2] rests on one narrative review's own synthesis of the field, not a device-level finding, and is marked [single-source].
Rescoped from class 3: The original question behind this report was closer to "would families and clinicians adopt a Bluetooth inhaler sensor or a home FeNO test for pediatric persistent asthma" — unanswerable in this form. The twin actually researched: which specific US-registered pediatric-persistent-asthma trials have tried to deploy this hardware, and what is their current status. Three such trials exist on ClinicalTrials.gov (§3, last sub-section); none has posted results, so even the revealed-behaviour twin currently returns "attempted, not yet resolved" rather than an answer.
Out of scope: No fda.gov guidance document on connected/software-driven inhaler accessories was fetched (named in the manifest's structural exclusions for intermittent bot mitigation). Non-US/EU clearance and reimbursement pathways for any device named above were not queried — no connector in this repo reaches them.
Not searched vs. not found: A keyword search for "acoustic cough monitoring machine learning pediatric asthma" returned zero PubMed records in the ten-year window — recorded here as not found, since it was searched directly under that exact phrasing rather than left unsearched. Patent-landscape search for inhaler-sensor or FeNO miniaturization was not searched: this repo's patent connector requires a specific known patent number rather than supporting keyword discovery, and no specific patent number was in hand to look up. Device-level pricing for any sensor or FeNO device named above was not searched.
[inference] The count of "at least 14 sensor-only devices" among the 50 shown CAF clearances in §3 is this report's own count of which titles in the returned list name a sensor/adherence product rather than a nebulizer, spacer, or accessory kit — the openFDA record itself does not distinguish sensor devices from nebulizer hardware within product code CAF, so a different reader applying the same title-level method to the full 59-record list (only 50 of which were returned) could arrive at a different count.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| FDA product code CAF has at least 59 510(k) clearances decided between 2016-09-05 and 2026-09-03, spanning nebulizers, spacers, and clip-on inhaler-adherence sensors | 1 registry | product code CAF; e.g. K222247 | technology |
| FDA product code MXA ("System, Test, Breath Nitric Oxide," 21 CFR 862.3080) has 7 510(k) clearances decided between 2016-09-05 and 2026-09-03 | 1 registry | product code MXA; e.g. K170983 | technology |
| Recall Z-1284-2021 against the Fenom Pro breath nitric oxide test (K182874) was initiated for erroneously high FeNO readings caused by calibration-gas drift and a software error | 1 registry | Z-1284-2021 | reference-products |
| NCT03648450 enrolled 50 children aged 10-18 with a history of persistent asthma to test feasibility/acceptability of the Propeller electronic medication monitor; the study is COMPLETED with no results posted | 1 registry | NCT03648450 | reference-products |
| A 164-adult comparative study found 32% of Vivatmo Me FeNO readings fell outside the device's claimed accuracy range against a NIOX VERO reference before a linear correction was applied | 2 published | PMID 40289685 | clinical-evidence |