# K242798: Airmod

- Pathway: 510(k) (Traditional)
- Applicant: Heroic Faith International, Ltd.
- Decided: Feb 28, 2025 after 165 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0, Covidien (2012) Summary page 5.

## Most influential descendants
- K243183: RTMsense Respiratory Monitoring System (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K242798
Methodology: https://510kreport.com/methodology