# K233953: Makani Science™ Respiration Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Makani Science, Inc.
- Decided: Mar 28, 2025 after 469 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)
- K220111: RespiraSense, Pmd Solutions (2022) Summary page 5.

## Indications for use
The Makani Science™ Respiration Monitoring System is indicated for continuous, non-invasive, and real-time monitoring of a patient’s breathing. It graphically displays respiration versus time and reports the respiratory rate value. The Makani Science™ Respiration Monitoring System is intended to be used by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older. It is not intended to be used as an apnea monitor.

Source page: https://510kreport.com/device/K233953
Methodology: https://510kreport.com/methodology