# K243183: RTMsense Respiratory Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Rtm Vital Signs, LLC
- Decided: Jun 27, 2025 after 270 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: 13 generations back to K962603 (1997). 77 ancestors in all.
No later device cites it as a predicate yet.
1 of 78 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242798: Airmod, Heroic Faith International, Ltd. (2025). Cleared while this submission was under review Summary page 6.
- K242971: AccurSound Electronic Stethoscope (AS101), Heroic Faith International, Ltd. (2024). Cleared while this submission was under review Summary page 6.
- K120984: Masimo Ras-125C Acoustic Respiration Sensor, Masimo Corporation (2013) Summary page 6.

## Indications for use
The RTMsense Respiratory Monitoring System is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and general wards, to monitor breathing in adult (at least 22 years old) patients. RTMsense Respiratory Monitoring System is a non-invasive system that graphically displays respiratory function against time and reports respiratory rate. RTMsense Respiratory Monitoring System measurements are used as an adjunct to other clinical information sources.

Source page: https://510kreport.com/device/K243183
Methodology: https://510kreport.com/methodology