# K191912: BiWaze Cough

- Pathway: 510(k) (Traditional)
- Applicant: Abmrc, LLC
- Decided: Mar 27, 2020 after 254 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 4.

## Indications for use
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and pediatric patients 3 years old and up.

Source page: https://510kreport.com/device/K191912
Methodology: https://510kreport.com/methodology