# K222018: Breathe+

- Pathway: 510(k) (Traditional)
- Applicant: Peep Medical, LLC Dba Go2 Devices
- Decided: Jun 2, 2023 after 329 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- 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 K962749 (1996). 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)
- K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port, Diemolding Corp. (1996) Summary page 4.

## Indications for use
The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.

Source page: https://510kreport.com/device/K222018
Methodology: https://510kreport.com/methodology