# K131586: Canary Breathing System

- Pathway: 510(k) (Traditional)
- Applicant: Palo Alto Health Sciences, Inc.
- Decided: Dec 10, 2013 after 193 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001359 (2000). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020399: Resperate; Model RR-150, Intercure, Ltd. (2002) Summary page 2.
- K053174: Loflo C5 CO2 Sensor, Respironics Novametrix, LLC (2006) Summary page 2.

## Most influential descendants
- K180173: Freespira (2018), 1 descendant of its own
- K222101: Prism (2023), 0 descendants of its own

## Indications for use
The Canary Breathing System is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Source page: https://510kreport.com/device/K131586
Methodology: https://510kreport.com/methodology