# K220111: RespiraSense

- Pathway: 510(k) (Traditional)
- Applicant: Pmd Solutions
- Decided: Oct 7, 2022 after 267 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: 33 generations back to K941811 (1994). 265 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO, Philips Medizin Systeme Boeblingen GmbH (2013) Summary page 4.

## Most influential descendants
- K233953: Makani Science™ Respiration Monitoring System (2025), 0 descendants of its own

## Indications for use
The RespiraSense is indicated for continuous, non-invasive, and real-time monitoring of respiratory rate. RespiraSense is indicated for patients 18 years and older in hospitals, hospital-type facilities and while patients are mobile (e.g., walking). RespiraSense is not intended to be an apnoea monitor.

Source page: https://510kreport.com/device/K220111
Methodology: https://510kreport.com/methodology