Anesthesiology · 510(k) · 2025
Airmod
Heroic Faith International Ltd.. Cleared by FDA on 28 February 2025 under submission K242798, product code BZQ (monitor, breathing frequency). What FDA's record says, in FDA's words.
Device record · K242798
- Device. AirmodDEVICE
- Company. Heroic Faith International Ltd. (TW)COMPANY
- Decision. 28 February 2025, 510(k), substantially equivalent (traditional review); received 16 September 2024DECISION
- Panel. AnesthesiologyPANEL
- Product code. BZQ, Monitor, Breathing FrequencyCODE
- Regulation. 21 CFR 868.2375, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Airmod, when used in conjunction with AccurSound Electronic Stethoscope AS-101, is a software as medical device intended to be used for the continuous, non-invasive monitoring of respiratory rate (RR) in adult patients who are subjected to procedural sedation and/or anesthesia. Airmod is intended for use by healthcare professionals in hospitals and healthcare facilities who are legally credentialed to perform procedural sedation and/or anesthesia. Airmod is intended for Android-based devices only.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 127 reports filed against devices carrying product code BZQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
1 June 2026 · Death · WEARABLE NASAL CANNUAL · CURRENT HEALTH LTD. · report MW5188818
PATIENT ADMITTED FOR RESPIRATORY FAILURE SENT HOME WEARING 4L NC. CALLED FOR PM ASSESSMENT AND WAS TOLD BY NEPHEW THAT PT WAS FOUND TO BE UNCONSCIOUS AND EMS CALLED; CPR INITIATED. PT SENT TO EMERGENCY DEPARTMENT WHERE SHE LATER PASSED. CURRENT HEALTH DEVICE DID NOT GIVE ANY ALARMS PRIOR TO THIS EVENT.
8 January 2026 · Malfunction · brand not stated · COVIDIEN LLC · report 2936999-2026-00008
IT WAS REPORTED THAT DURING THE INITIAL PHASE OF LAPAROSCOPY, THE PATIENT'S READING INCREASED FROM 46 TO 90, WITHOUT ANY CHANGE IN THE ADMINISTRATION OF THE INHALED HYPNOTIC OR ANY OTHER EVENT. THE ADMINISTRATION DEVICES, ENDOTRACHEAL TUBE, VENTILATOR TUBING, SEV OFLURANE DELIVERY CASSETTE, AND MONITORING EQUIPMENT WERE CHECKED. THE SEVOFLURANE INHALATION TARGET WAS ADJUSTED TO MATCH THE ADMINISTRATION VIA THE FLOW-I SYSTEM. HEMODYNAMIC PARAMETERS REMAINED STABLE WITH A LINEAR HEART RATE. THE […]
16 September 2022 · Malfunction · MASIMO SLEEP · MASIMO - 15750 ALTON PKWY · report 3019388613-2022-00210
PER MEDWATCH RECEIVED: "MASIMO PERSONAL SLEEP MONITOR OXYGEN MONITOR REPORTS OXYGEN LEVELS INCORRECTLY AND/OR DOES NOT CONNECT TO BLUETOOTH WHEN USING MOTOROLA SYLUS OR GOOGLE PIXEL 3A CELL PHONES. THE DEVICE MAY BE USED TO TRACK SLEEP APNEA OR OTHER HEALTH CONDITIONS: HTTPS://WWW.MASIMOPERSONALHEALTH.COM/PAGES/MASIMO-SLEEP. I CONTACTED THE COMPANY SEVERAL TIMES BUT THEY ARE UNABLE TO PROVIDE A TECHNICAL FIX FOR THE PROBLEM. THE DEVICE IS ADVERTISED AS BEING COMPATIBLE WITH ANDROID PHONES, BUT […]
23 August 2022 · Malfunction · PERSONAL SLEEP MONITOR · MASIMO CORPORATION · report MW5111676
MASIMO PERSONAL SLEEP MONITOR OXYGEN MONITOR REPORTS OXYGEN LEVELS INCORRECTLY AND/OR DOES NOT CONNECT TO BLUETOOTH WHEN USING MOTOROLA SYLUS OR GOOGLE PIXEL 3A CELL PHONES. THE DEVICE MAY BE USED TO TRACK SLEEP APNEA OR OTHER HEALTH CONDITIONS: HTTPS://WWW.MASIMOPERSONALHEALTH.COM/PAGES/MASIMO-SLEEP I CONTACTED THE COMPANY SEVERAL TIMES BUT THEY ARE UNABLE TO PROVIDE A TECHNICAL FIX FOR THE PROBLEM. THE DEVICE IS ADVERTISED AS BEING COMPATIBLE WITH ANDROID PHONES, BUT IS NOT COMPATIBLE WITH […]
20 April 2021 · Malfunction · MP5 · PHILIPS MEDICAL SYSTEMS · report 9610816-2021-00068
THE CUSTOMER REPORTED THAT THE DEVICE HAD FALLEN. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT WAS REPORTED.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code BZQ, in Anesthesiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.