# K180173: Freespira

- Pathway: 510(k) (Traditional)
- Applicant: Palo Alto Health Sciences, Inc.
- Decided: Aug 23, 2018 after 213 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: 6 generations back to K001359 (2000). 9 ancestors in all.
1 later device descends 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)
- K131586: Canary Breathing System, Palo Alto Health Sciences, Inc. (2013) Summary page 5.

## Most influential descendants
- K222101: Prism (2023), 0 descendants of its own

## Indications for use
Freespira 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 (PD) and/or posttraumatic stress disorder (PTSD), 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/K180173
Methodology: https://510kreport.com/methodology