# K963349: Devilbiss 8650D

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Health Care, Inc.
- Decided: Jun 13, 1997 after 291 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Allied Healthcare/Timeter PCS414: named in the summary without a submission number

## Most influential descendants
- K072634: Emg Triton -Comp,Model NCA01-XXX Series (2008), 0 descendants of its own

## Indications for use
The 8650D will be used as the air source to nebulize sterile water to prdvide humidification to patients with tracheostomies. The 8650D may also be used to nebulize medications in the treatment of Asthma, Cystic Fiprosis, and chronic obstructive pulmonary disease.

Source page: https://510kreport.com/device/K963349
Methodology: https://510kreport.com/methodology