# K993492: Devilbiss Nebulizer Model 800

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical Hhg, Inc.
- Decided: Apr 21, 2000 after 189 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 K894555 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952249: Jet Nebulizer, Devilbiss Health Care, Inc. (1996) Summary page 1.
- K894555: Pari Inhalierboy Type 37.80 Double Insulated, Dura Pharmaceuticals, Inc. (1990) Summary page 1.
- K896984: Pari I.S.-2, Dura Pharmaceuticals, Inc. (1990) Summary page 1.

## Most influential descendants
- K082878: Nevoni Classic, Model 6600-PO (2008), 0 descendants of its own

## Indications for use
The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.

Source page: https://510kreport.com/device/K993492
Methodology: https://510kreport.com/methodology