# K151689: MetaNeb 4 System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Services Pte, Ltd.
- Decided: Mar 17, 2016 after 268 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: 4 generations back to K944900 (1995). 6 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K124032: Metaneb, Hill-Rom Services Pte, Ltd. (2013) Summary page 4.
- K051964: Powerneb, Comedica, Inc. (2005) Summary page 4.
- K895485: Bird (Ipv) Noncontinuous Ventilators, Percussionaire Corp. (1989) Summary page 4.

## Most influential descendants
- 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
- K213564: BiWaze Clear System (2022), 0 descendants of its own

## Indications for use
The MetaNeb® 4 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 – 5 years old and above whom can follow verbal instructions. Environment of Use – Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings

Source page: https://510kreport.com/device/K151689
Methodology: https://510kreport.com/methodology