# K233580: A Breathing System (ABS)

- Pathway: 510(k) (Traditional)
- Applicant: Deepwell Dtx, Inc.
- Decided: Aug 1, 2024 after 268 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: 2 generations back to K000405 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.

## Indications for use
A Breathing System (ABS) is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.

Source page: https://510kreport.com/device/K233580
Methodology: https://510kreport.com/methodology