Entrants, exits, funding, launches, recalls — pediatric obstructive sleep apnea testing

1. Summary

The broader home-sleep-apnea-test product code (MNR) has seen sustained new-entrant activity — 37 510(k) clearances from 22 distinct applicants between September 2020 and September 2026 — but that growth is overwhelmingly adult-labeled [1]. Of the device indications spot-checked this pass, only three carry any pediatric-eligible age language: SNAP Diagnostics' SAM Model 9-10000 ("both pediatric and adult patients may be tested") [2], the Itamar/ZOLL WatchPAT family down to age 12 for most parameters [3][4], and Dormotech Medical's DormoTech Nlab for patients "greater than 6 years of age" [5]; several others checked (Ectosense's NightOwl, Wesper's CASSIE) are explicitly adult-only [6][7]. Two companies are running pediatric-population validation studies for devices that are not yet pediatric-labeled: ResMed completed a 12-17-year-old validation of its adult-cleared ApneaLink Air, with results posted but not retrieved by this pass [10], and Wesper Inc. is sponsoring a 2-21-year-old feasibility study for its Wesper Lab device, last updated with status UNKNOWN and no results [11]. One academic, NIH-linked trial (Children's Hospital of Philadelphia) is directly comparing pediatric HSAT to in-lab PSG and remains recruiting with no results posted [12]. Exactly one FDA device recall touched this product code in the last six years, and it named a firmware position-detection defect unrelated to pediatric use [9]. No company entry into, or exit from, a pediatric-specific HSAT segment was located from a primary source carrying a resolvable identifier this pass.

2. What Changed

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

3. Details

Entrants: a crowded adult HSAT product code, thin on pediatric label language

A rescan of openFDA's device/510(k) endpoint for product code MNR, window 2020-09-03 to 2026-09-02, returns 37 cleared devices from 22 distinct applicants, ranging from Itamar Medical/ZOLL's five WatchPAT-line clearances to single-clearance entrants such as Withings, Largan Medical and Huneo, LLC [1]. The most recent clearance in the window is Huneo, LLC's WRAP System (K260050, decided 2026-07-15), and the most recent WatchPAT-line clearance is WatchPAT SW (K254042, decided 2026-07-31) [1]. This is the same product code the domain dossier's reference-products section already anchors its pediatric-device discussion on, and this report extends that section's single-device check (SNAP's K240100) across a wider slice of the same roster [1].

Pediatric-eligible clearances found this pass

Spot-checking Indications for Use text across seven of the 37 clearances found pediatric-eligible language in three: SNAP Diagnostics' SAM Model 9-10000 (K240100, decided 2024-06-04), whose summary states verbatim "Both pediatric and adult patients may be tested," with use required "under the direct supervision of a qualified adult (parent or guardian) or health care practitioner" [2]; the WatchPAT family, most recently updated via WatchPAT SW (K254042, decided 2026-07-31), whose summary reads "Central indices are indicated for use in patients 17 years and older. All other outputs are indicated for 12 years and older," language that traces back to WatchPAT ONE's original K223675 clearance (decided 2023-01-06) [3][4]; and Dormotech Medical's DormoTech Nlab (K242290, decided 2025-01-08), a physiological data recorder "intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments" [5]. Against those three, two other checked devices are explicitly adult-only: Ectosense NV's NightOwl (K213463, decided 2021-12-16) is indicated for "adult patients suspected of sleep apnea" [6], and Wesper Inc.'s CASSIE (K252628, decided 2025-04-27) "may inform or drive clinical management for adults" [7]. ResMed's own ApneaLink line, the predicate for its adolescent validation study below, was itself originally cleared for adults in 2007 (K070263) [8].

Company-sponsored pediatric validation trials — no pediatric label secured yet

Two industry sponsors are running pediatric-population studies of devices cleared only for adults. ResMed's NCT03748771, "Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children," enrolled 20 participants aged 12-17, completed, and has results posted (hasResults=true) that this report did not retrieve [10]. Wesper Inc.'s NCT06218186, "Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations," targets 150 participants aged 2-21 [sponsor-reported], is a single-arm, industry-sponsored study, and its registry status is UNKNOWN with no results posted [11].

Academic/NIH-linked pediatric HSAT trial

Children's Hospital of Philadelphia sponsors NCT05382754, "Home Apnea Testing in CHildren Trial," a randomized crossover comparison of HSAT to in-lab PSG in children aged 5-12, target enrollment 317 [sponsor-reported], status RECRUITING, no results posted [12]. Its title and population match an NIH-funded project line this report located but could not carry forward as a numbered source (see §5, Out of scope).

Recalls

One FDA device recall was initiated in product code MNR over the past six years: Z-0031-2022, Nox Medical's Nox T3s Recorder, initiated 2021-09-07, status Terminated, stated reason "Error in the device firmware results in the inaccurate detection of device position," related to 510(k) K082113 [9]. Nothing in the recall record ties it to pediatric use specifically, and no other recall in this product code was found in the same window [9].

Exits

No company entry into, or exit from, a pediatric-specific HSAT segment was retrieved from a primary source carrying a resolvable identifier this pass; see §5 for what a WebSearch surfaced and why it was excluded.

4. Sources

[1] openFDA device/510(k) scan, product_code=MNR, window 2020-09-03 to 2026-09-02 — FDA CDRH (queried 2026-09-01; accessed 2026-09-01). 37 records, 22 distinct applicants, including K260050, K254042, K250460, K242290, K240100, K223675 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm [federal-registry] [2] FDA 510(k) summary K240100 — SAM Model 9-10000, Snap Diagnostics, LLC (decision 2024-06-04; accessed 2026-09-01). Indications for Use, verbatim: "Both pediatric and adult patients may be tested." K240100 — https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240100.pdf [federal-registry] [3] FDA 510(k) summary K223675 — WatchPAT ONE (WP1), Itamar Medical, Ltd. (decision 2023-01-06; accessed 2026-09-01). Indications for Use include: "PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older." K223675 — https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223675.pdf [federal-registry] [4] FDA 510(k) summary K254042 — WatchPAT SW, Itamar Medical, Ltd. (decision 2026-07-31; accessed 2026-09-01). Indications for Use, verbatim: "Central indices are indicated for use in patients 17 years and older. All other outputs are indicated for 12 years and older." K254042 — https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254042.pdf [federal-registry] [5] FDA 510(k) summary K242290 — DormoTech Nlab, Dormotech Medical, Ltd. (decision 2025-01-08; accessed 2026-09-01). Indications for Use, verbatim: "It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments." K242290 — https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242290.pdf [federal-registry] [6] FDA 510(k) summary K213463 — NightOwl, Ectosense NV (decision 2021-12-16; accessed 2026-09-01). Indications for Use include: "aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea." K213463 — https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213463.pdf [federal-registry] [7] FDA 510(k) summary K252628 — CASSIE, Wesper, Inc. (decision 2025-04-27; accessed 2026-09-01). Indications for Use include: "may inform or drive clinical management for adults." K252628 — https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252628.pdf [federal-registry] [8] openFDA device/510(k) record K070263 — APNEALINK, Resmed Germany, Inc. (decision 2007-06-15; accessed 2026-09-01). K070263 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070263 [federal-registry] [9] openFDA device/recall record Z-0031-2022 — Nox T3s Recorder, Nox Medical (initiated 2021-09-07, status Terminated; accessed 2026-09-01). Z-0031-2022, related 510(k) K082113 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [10] ClinicalTrials.gov NCT03748771 — "Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children," sponsor ResMed (record last updated 2021-11-15; accessed 2026-09-01). Status COMPLETED, enrollment 20 (ACTUAL), ages 12-17, hasResults=true (not retrieved). NCT03748771 — https://clinicaltrials.gov/study/NCT03748771 [trial-registry] [11] ClinicalTrials.gov NCT06218186 — "Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations," sponsor Wesper Inc (record last updated 2024-01-23; accessed 2026-09-01). Status UNKNOWN, enrollment 150 (ESTIMATED), ages 2-21, hasResults=false. NCT06218186 — https://clinicaltrials.gov/study/NCT06218186 [trial-registry] [12] ClinicalTrials.gov NCT05382754 — "Home Apnea Testing in CHildren Trial," sponsor Children's Hospital of Philadelphia (record last updated 2026-04-21; accessed 2026-09-01). Status RECRUITING, enrollment 317 (ESTIMATED), ages 5-12, hasResults=false. NCT05382754 — https://clinicaltrials.gov/study/NCT05382754 [trial-registry] [13] openFDA device/classification record, product_code=MNR — "Ventilatory Effort Recorder," Class II, regulation 868.2375, review panel AN, FDA CDRH (issue date not stated in record; accessed 2026-09-01). 21 CFR 868.2375 — https://open.fda.gov/apis/device/classification/ [federal-registry]

5. Sourcing & Gaps

Well established: The 37-clearance, 22-applicant count in product code MNR over the 2020-2026 window rests on a single federal registry queried directly this pass [1][13] — a registry fact stated plainly per this fleet's convention that one authoritative registry lookup is not the same kind of gap as one journal article, even though only one source exists. The one MNR recall in the same window [9] rests on the same registry.

Thin: Every device-level Indications-for-Use quote ([2] through [8]) rests on a single 510(k) summary PDF apiece — this report did not seek a second, independent source for wording FDA itself publishes, consistent with how the domain dossier already treats its own 510(k) quotes. Each trial registration ([10], [11], [12]) is [sponsor-reported]: every enrollment figure that is ESTIMATED rather than ACTUAL is the sponsor's target, not a count of anyone enrolled, and none of the three trials has a result this report retrieved or read.

Rescoped from class 3: "Will device makers pursue a pediatric indication for HSAT?" is a class-3 question about future intent with no answerable form. Its answered twin, worked in §3 above, is: which named applicants currently hold a pediatric-eligible IFU in this product code, and which have registered a pediatric-population trial for a device that does not yet carry one. Three applicants answer the first description [2][3][4][5]; two answer the second [10][11], plus one non-industry academic trial [12].

Out of scope: MAUDE complaint narratives for any named device (no connector in this repo). Company financial filings, funding-round announcements, and ownership-change data — a research-funding-scan run this pass for the term "pediatric home sleep apnea test" returned ten NIH RePORTER award records, including a four-part R61/R33 grant series (project numbers 1R61HL162839-01, 4R33HL162839-02, 5R33HL162839-03, 5R33HL162839-04) whose title matches NCT05382754's own title exactly, and one award (1R61HL162839-01) was independently confirmed to exist via a direct project-number lookup; none of those award records is carried into §3 or §4 as a numbered finding, because an NIH project number does not match any pattern in this fleet's resolvable-identifier list (PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX, or FR Doc number) — the same disqualification this task's brief already names for an SEC EDGAR accession number. A WebSearch (not followed by a successful primary-document retrieval with a resolvable identifier) surfaced trade-press claims of a $75 million funding round for Happy Health, a $29 million Series A for a company called Sunrise, and a ResMed-branded relaunch of the NightOwl device — none of these is entered as a source: the funding-round figures were not independently retrieved from a primary document, and NightOwl's own FDA-cleared Indications for Use remain adult-only as quoted in §3 and §4 [6], which the trade-press claim does not address. Non-US regulatory status and any jurisdiction outside the US were not queried (no connector in this repo reaches a non-US registry).

Not searched vs. not found: Not found — any FDA recall record naming SNAP Diagnostics, Dormotech Medical, Itamar Medical/ZOLL, ResMed, or Wesper Inc. specifically (each was implicit in the product-code-wide recall scan [9], which returned only the Nox Medical record). Not searched — Indications-for-Use text for the remaining 30 of the 37 clearances in [1]; the seven checked this pass ([2] through [8]) were chosen for name-recognition and recency, not by a systematic rule, so the true count of pediatric-eligible clearances in this product code could be higher than three. Not searched — whether any of the 22 applicants named in [1] has since been acquired, merged, or ceased operating; no business-registration or dissolution registry is queried by any connector in this repo.

[inference] The near-total absence of pediatric-eligible label language across a rapidly growing, adult-oriented HSAT clearance roster, set against two industry sponsors' own decisions to run pediatric-population validation studies on devices they have not yet relabeled, reads as firms treating pediatric HSAT as a validation-stage question rather than a commercial one as of this pass — a synthesis of the pattern across §3, not a finding stated by any cited source.

6. Claim Candidates