# K251326: Respiration Rate algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 11, 2026 after 408 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: 30 generations back to K941811 (1994). 286 ancestors in all.
No later device cites it as a predicate yet.
2 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0, Covidien (2012) Summary page 5.
- K223865: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor, Edwards Lifesciences, LLC (2023) Summary page 5.

## Indications for use
The Respiration Rate algorithm is indicated for continuous measurement of respiration rate in patients over 18 years of age using compatible non-invasive blood pressure finger cuffs or compatible minimally invasive blood pressure sensors during no motion conditions in environments where health care is provided by clinicians.

Source page: https://510kreport.com/device/K251326
Methodology: https://510kreport.com/methodology