# K051964: Powerneb

- Pathway: 510(k) (Traditional)
- Applicant: Comedica, Inc.
- Decided: Dec 1, 2005 after 134 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: 2 generations back to K944900 (1995). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895485: Bird (Ipv) Noncontinuous Ventilators, Percussionaire Corp. (1989) Summary page 1.
- K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device, Dhd Healthcare Corp. (1999) Summary page 1.

## Most influential descendants
- K124032: Metaneb (2013), 6 descendants of its own
- K151689: MetaNeb 4 System (2016), 5 descendants of its own
- K192143: Maximus System (2020), 4 descendants of its own
- K200988: Maximus System (2020), 3 descendants of its own
- K231728: BiWaze Clear System (2024), 1 descendant of its own

## Indications for use
PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Source page: https://510kreport.com/device/K051964
Methodology: https://510kreport.com/methodology