# K250934: Respiree Cardio- Respiratory Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Respiree Pte, Ltd.
- Decided: Aug 5, 2025 after 130 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: 34 generations back to K941811 (1994). 266 ancestors in all.
No later device cites it as a predicate yet.
2 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223681: Respiree Cardio-Respiratory Monitor, Respiree Pte, Ltd. (2023) Summary page 5.

## Indications for use
The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospitals and hospital-type facilities in non-ICU settings and home 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/K250934
Methodology: https://510kreport.com/methodology