# K922623: Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne, Inc.
- Decided: Dec 1, 1992 after 182 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970289: Compressor/Nebulizer #3650 (1997), 4 descendants of its own
- K020932: Devilbiss Pulmo-Aide Compact Compressor (2002), 3 descendants of its own
- K161586: The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (2017), 0 descendants of its own
- K082878: Nevoni Classic, Model 6600-PO (2008), 0 descendants of its own
- K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K922623
Methodology: https://510kreport.com/methodology