# K223681: Respiree Cardio-Respiratory Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Respiree Pte, Ltd.
- Decided: Mar 8, 2023 after 90 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
- K250934: Respiree Cardio- Respiratory Monitor System (2025), 0 descendants of its own

## Indications for use
The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospitals and hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.

Source page: https://510kreport.com/device/K223681
Methodology: https://510kreport.com/methodology