# K213564: BiWaze Clear System

- Pathway: 510(k) (Traditional)
- Applicant: Abmrc, LLC
- Decided: Dec 21, 2022 after 407 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.
No later device cites it as a predicate yet.
2 of 14 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 4.

## Indications for use
The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

Source page: https://510kreport.com/device/K213564
Methodology: https://510kreport.com/methodology