# K231728: BiWaze Clear System

- Pathway: 510(k) (Traditional)
- Applicant: Abmrc, LLC
- Decided: Apr 8, 2024 after 300 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: 7 generations back to K944900 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200988: Maximus System, Hill-Rom Services Pte, Ltd. (2020) Summary page 5.

## Most influential descendants
- K260604: BiWaze Clear System (2026), 0 descendants of its own

## 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 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 may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

Source page: https://510kreport.com/device/K231728
Methodology: https://510kreport.com/methodology