Airmod

K242798

Heroic Faith International Ltd. · cleared 2025-02-28 · product code BZQ · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“AirmodTM is an Android-based software application designed to aid healthcare professionals by monitoring a sedated and/or anesthetized patient's breathing in real time. The device has an AI-based algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101.”
AlgorithmAI-based algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101.
source quote (p.1)
“The device has an AI-based algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.4)
“Cybersecurity testing per FDA's guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304, FDA's guidance Content of Premarket Submissions for Device Software Functions, FDA's guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Retrospective clinical

n=270 patients

endpoints: difference in respiratory rate measurements between AirmodTM (airRR) and manual scored capnography (mancRR) with a performance goal of Root Mean Square Error (RMSE) < 3 breaths per minute (BPM); performance during periods of abnormal end-tidal CO2 graphs (ETF)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
+50%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Anesthesiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242798