# K970289: Compressor/Nebulizer #3650

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Health Care, Inc.
- Decided: Apr 15, 1997 after 81 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922623 (1992). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923888: Devilbiss Model 5650 Pulmo-Aide, Devilbiss Health Care, Inc. (1993) Summary page 1.
- K922623: Nebulizer System, Healthdyne, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- K062952: C300 Series Air Nebulizer Compressor (2007), 0 descendants of its own

## Indications for use
The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.

Source page: https://510kreport.com/device/K970289
Methodology: https://510kreport.com/methodology