# K124032: Metaneb

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Services Pte, Ltd.
- Decided: Apr 25, 2013 after 118 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 K944900 (1995). 5 ancestors in all.
6 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)
- K051964: Powerneb, Comedica, Inc. (2005) Summary page 1.
- K895485: Bird (Ipv) Noncontinuous Ventilators, Percussionaire Corp. (1989) Summary page 1.

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

## Indications for use
The MetaNeb® System 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. Patient population - Adult and Children > 2 years old Environments of use - Hospitals, sub-acute facilities, physician offices, and clinics.

Source page: https://510kreport.com/device/K124032
Methodology: https://510kreport.com/methodology