# K242438: Clearo

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: May 16, 2025 after 273 days
- Product code: NHJ (Device, Positive Pressure Breathing, Intermittent)
- 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: 3 generations back to K002598 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121955: Coughassist T70 Device, Respironics, Inc. (2012) Summary page 5.

## Indications for use
Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

Source page: https://510kreport.com/device/K242438
Methodology: https://510kreport.com/methodology