# K130037: Breathe Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Breathe Technologies, Inc.
- Decided: May 17, 2013 after 130 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070609 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070609: Apex Medical XT1 Cpap, Model 9S-005, Apex Medical Corp. (2007) Summary page 1.

## Indications for use
The continuous positive airway pressure (CPAP) System is indicated for the treatment of obstructive sleep apnea (OSA) in patients > 66 lb (30 kg). The Breathe CPAP System is intended for single-patient re-use in the home environment.

Source page: https://510kreport.com/device/K130037
Methodology: https://510kreport.com/methodology