Entrants, exits, funding, launches, recalls — pediatric persistent asthma home monitoring

1. Summary

This domain's existing dossier sweeps two hardware product codes — diagnostic spirometers (BZG) and peak-flow meters (BZH) — and explicitly flags that funding, acquisition and company-exit activity for a pediatric-asthma-RPM segment was never searched. This report searches a third, adjacent hardware category instead: connected medication-adherence and inhaler-sensor devices, which sit under FDA product codes CAF and DSH rather than BZG/BZH. Four named firms hold US 510(k) clearances in this category — Reciprocal Labs Corporation ("Propeller Health"), Adherium (Nz), Ltd. ("Smartinhaler"/"Hailie"), Ochsner Clinic Foundation, and Aevice Health Pte. Ltd. ("AeviceMD") — spanning 2014 through 2025, with no recalls found for any of them. Three of the four also sponsor or appear as the named intervention in ClinicalTrials.gov records that include pediatric persistent-asthma populations specifically. No funding round, acquisition, or corporate-exit event for any of these four firms could be sourced to an identifier this fleet's checker accepts; that gap is recorded in section 5 rather than filled with an uncitable claim.

2. What Changed

_Baseline (v1). No prior version; this establishes the starting point for future diffs._

3. Details

Connected inhaler-sensor entrants — a segment this dossier's spirometer/peak-flow sweep did not cover

FDA's own classification record for product code CAF names it "Nebulizer (Direct Patient Interface)" (21 CFR 868.5630, Class II) [5] — a legacy label; in practice this is the code under which FDA has cleared every MDI-actuation sensor found this pass:

• Reciprocal Labs Corporation, "Propeller System" — four clearances: K140638 (2014-05-02, "Propeller System - Model 2"), K142960 (2015-03-05, "Propeller System 2014-R"), K142516 (2015-05-15), K152882 (2016-03-08) [1].
• Adherium (Nz), Ltd., "Smartinhaler"/"Hailie Sensor" — eight clearances between 2018-07-25 and 2023-02-08: K180407 (Smartinhaler), then seven Hailie Sensor model variants — K181405, K182573, K182638, K211233, K220622, K221994, K222247 — clustered in 2018-2019 and again in 2021-2023 [2].
• Ochsner Clinic Foundation, "Ochsner Connected Inhaler Sensor" — one clearance, K223367 (2023-08-30). Its FDA-cleared Indications for Use state, verbatim: "The System is intended to be used in populations from Child (>2 years) to adult" and that, "used under the care of a physician with a prescribed MDI," it "can assist in the management of respiratory health symptoms and exacerbations" [3] — the only one of the four with a pediatric age floor written directly into its own cleared labeling, and a health-system-branded entrant rather than a device-company one.

A separate product code, DSH — FDA's classification record names it "Recorder, Magnetic Tape, Medical" (21 CFR 870.2800, Class II) [6], again a legacy label rather than a literal description — covers a different device shape:

• Aevice Health Pte. Ltd. ("AeviceMD") — two clearances, K223382 (2023-07-07) and K243603 (2025-05-05) [4], a wearable lung-sound/wheeze recorder rather than an inhaler-actuation counter. Aevice Health is Singapore-domiciled; both clearances are US 510(k)s.

Recalls: no recall was found for Reciprocal Labs/Propeller Health, Adherium, Ochsner Clinic Foundation, or Aevice Health under either product code in any window searched. The 26 CAF-coded recalls that do exist between 2014 and 2026 are all conventional nebulizer, spacer, humidifier, or saline-vial hardware from unrelated firms (Smiths Medical, Salter Labs, Valeant, Medline, and others), none naming any of the four sensor firms or their K-numbers [7]. Zero recalls exist under DSH in the same window [8].

Registered trials naming these firms in a pediatric persistent-asthma population

• NCT01509183, sponsor Reciprocal Labs (industry) — an interventional demonstration project with Dignity Health (then Catholic Healthcare West) evaluating the Propeller Health approach; completed, actual enrollment 495, population ages 5-90 [9]. This is a broad current-asthma deployment, not persistent-asthma-specific, and its posted results are the sponsor's own (hasResults=true; unappraised here) [sponsor-reported].
• NCT02735174, sponsor Children's Hospital Medical Center, Cincinnati — a pilot ("asthma-free schools") naming the Propeller Health platform as intervention, restricted to ages 10-17 with uncontrolled persistent asthma per NAEPP criteria; completed, actual enrollment 21 [10].
• NCT02999789, sponsor University of California, San Francisco — a reminder-system pilot using an Adherium sensor, explicitly enrolling children "ages 5 to 17 years with a diagnosis of persistent asthma" whose guardians manage a daily MDI controller; the protocol's own eligibility text describes a target of 30 participants, and the trial's registered actual enrollment on completion was 13 [11].
• NCT05194436 and NCT06691971, both sponsor Aevice Health Pte. Ltd. (industry) — wheeze-detection studies distinct from the individually-investigator-sponsored AeviceMD pilot already in this dossier (NCT06321471). NCT05194436 enrolled ages 3-18, completed, actual enrollment 35, no results posted [sponsor-reported] [12]. NCT06691971 enrolls ages 3 and up in an ED setting, status recruiting, enrollment target 160 (ESTIMATED) [sponsor-reported] [13].

Read together, these are the closest thing to continued market activity this pass could find in the connected-inhaler-sensor segment: two of the four firms (Adherium and Aevice Health) are still filing new 510(k)s and sponsoring new trials as recently as 2025, and none of the four shows a recall or a withdrawn/terminated trial record of its own.

Funding, acquisitions, and market exits

Not established this pass — see section 5. Cohero Health was searched by device name (510(k)) and by company name (NIH RePORTER) and produced no US 510(k) record and no NIH award; recorded as searched, not found, not simply unsearched.

4. Sources

[1] openFDA 510(k) clearances, device_name="Propeller System", Reciprocal Labs Corporation — K140638, K142960, K142516, K152882 (2014-05-02 to 2016-03-08) — accessed 2026-09-01. K140638 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140638 [federal-registry] [2] openFDA 510(k) clearances, device_name="Hailie"/"Smartinhaler", Adherium (Nz), Ltd. — K180407, K181405, K182573, K182638, K211233, K220622, K221994, K222247 (2018-07-25 to 2023-02-08) — accessed 2026-09-01. K222247 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222247 [federal-registry] [3] openFDA 510(k) K223367 and FDA 510(k) summary — Ochsner Connected Inhaler Sensor, Ochsner Clinic Foundation, decided 2023-08-30 — accessed 2026-09-01. K223367 — https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223367.pdf [federal-registry] [4] openFDA 510(k) clearances, device_name="AeviceMD", Aevice Health Pte. , Ltd. — K223382 (2023-07-07), K243603 (2025-05-05) — accessed 2026-09-01. K243603 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243603 [federal-registry] [5] openFDA device/classification, product_code=CAF — "Nebulizer (Direct Patient Interface)," Class II, 21 CFR 868.5630 — accessed 2026-09-01. 21 CFR 868.5630 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=CAF [federal-registry] [6] openFDA device/classification, product_code=DSH — "Recorder, Magnetic Tape, Medical," Class II, 21 CFR 870.2800 — accessed 2026-09-01. 21 CFR 870.2800 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=DSH [federal-registry] [7] openFDA device/recall, product_code=CAF, 2014-09-05 to 2026-09-02 (26 records; none naming Reciprocal Labs, Adherium, Ochsner Clinic Foundation, or Aevice Health) — accessed 2026-09-01. Z-2514-2023 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [8] openFDA device/recall, product_code=DSH, 2014-09-05 to 2026-09-02 (0 records) — accessed 2026-09-01. 21 CFR 870.2800 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [9] ClinicalTrials.gov NCTId=NCT01509183 — "Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System," sponsor Reciprocal Labs, status COMPLETED, enrollment 495 (ACTUAL), population 5-90 years — accessed 2026-09-01. NCT01509183 — https://clinicaltrials.gov/study/NCT01509183 [trial-registry] [10] ClinicalTrials.gov NCTId=NCT02735174 — "Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools," sponsor Children's Hospital Medical Center, Cincinnati, status COMPLETED, enrollment 21 (ACTUAL), population 10-17 years — accessed 2026-09-01. NCT02735174 — https://clinicaltrials.gov/study/NCT02735174 [trial-registry] [11] ClinicalTrials.gov NCTId=NCT02999789 — "Interventions To Help Asthma Clinical Adherence," sponsor University of California, San Francisco, status COMPLETED, enrollment 13 (ACTUAL), population 5-17 years — accessed 2026-09-01. NCT02999789 — https://clinicaltrials.gov/study/NCT02999789 [trial-registry] [12] ClinicalTrials.gov NCTId=NCT05194436 — "Wheeze Detection Using Aevice Medical Device," sponsor Aevice Health Pte. Ltd., status COMPLETED, enrollment 35 (ACTUAL), hasResults=false, population 3-18 years — accessed 2026-09-01. NCT05194436 — https://clinicaltrials.gov/study/NCT05194436 [trial-registry] [13] ClinicalTrials.gov NCTId=NCT06691971 — "AeviceMD for Detection of Wheeze in Pediatric and Adult Populations," sponsor Aevice Health Pte. Ltd., status RECRUITING, enrollment 160 (ESTIMATED), population 3+ years — accessed 2026-09-01. NCT06691971 — https://clinicaltrials.gov/study/NCT06691971 [trial-registry]

5. Sourcing & Gaps

Well established: the 510(k) clearance roster for Reciprocal Labs/Propeller Health, Adherium, Ochsner Clinic Foundation, and Aevice Health under product codes CAF and DSH [1] [2] [3] [4], and the absence of any recall naming those firms under either code [7] [8], each rest on a direct openFDA registry query — a single authoritative federal source per fact, not a disputed account requiring corroboration.

Thin: the trial-registry findings in section 3 each rest on one ClinicalTrials.gov record apiece [9] [10] [11] [12] [13]; enrollment figures marked (ESTIMATED) or drawn from a trial whose own results are unposted carry [sponsor-reported] per this fleet's marker rules. NCT01509183's population (5-90 years) is not persistent-asthma-specific and is reported here only as the largest deployment-scale study located, not as pediatric-persistent evidence.

Rescoped from class 3: none in this report. Nothing here answers what an investor, acquirer, or company "would" do; every line is a registry or trial-registry record of what was actually filed, cleared, or registered.

Out of scope: SEC filings (10-K, 8-K, S-1) and any accession-number-anchored source — explicitly excluded by this fleet's identifier checker, which does not accept an SEC accession number as a resolvable identifier. Company press releases and funding-round trade coverage were not fetched for the same reason: even where retrievable, they carry no PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX, or Federal Register document number, so citing one here would produce a source this report's own checker refuses.

Not searched vs. not found: Cohero Health was searched — by 510(k) device name and by NIH RePORTER company-name term — and found nothing; that is a not found, not a gap left untouched. Funding rounds and acquisition/exit events for all four named firms are not searched with a compliant source, not confirmed absent: NIH RePORTER's free-text search on "Propeller Health" returned ten records, none of them actually about the company (top hits concerned selenoprotein signaling and Plasmodium falciparum drug resistance) — a false- positive match on the word "propeller," not evidence of NIH funding, and is not cited above for that reason. State Medicaid, non-US, and non-FDA jurisdictions were not searched.

[inference] The clustering of Adherium's eight clearances into two 2018-2019 and 2021-2023 groups, and Aevice Health's second AeviceMD clearance in 2025, read as continued product investment by both firms rather than a one-time filing — this is this report's own reading of the filing dates, not a fact either firm has stated.

6. Claim Candidates