# K260604: BiWaze Clear System

- Pathway: 510(k) (Traditional)
- Applicant: Abmrc, LLC
- Decided: Aug 24, 2026 after 181 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: 8 generations back to K944900 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231728: BiWaze Clear System, Abmrc, LLC (2024) Summary page 5.

## Indications for use
The BiWaze® Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply. The system provides three therapies: Positive Expiratory Pressure (PEP), Oscillation (OSC), and delivery of saline via integrated nebulizer (NEB). The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older). The BiWaze Clear System is compatible with various patient interfaces including face mask, mouthpiece, a trach adapter for connection to an endotracheal or tracheostomy tube in acute and home care settings. The BiWaze Clear System may be used in-line with a ventilator in acute care environments only.

Source page: https://510kreport.com/device/K260604
Methodology: https://510kreport.com/methodology