# K973468: Model Irc 1199 Scout Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Dec 8, 1997 after 87 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 K946095 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954327: Medox Champion Compact Nebulizer, Medox Corp. (1995) Summary page 1.
- K946095: Devilbiss Model 5500, Devilbiss Health Care, Inc. (1995) Summary page 1.

## Indications for use
Used for the delivery of aerosol medication for treatment of various respiratory conditions, such as asthma, on patients from adolescence through adults. Intended for indoor and outdoor use (50°F - 104°F, 15%-95% non condensing humidity)

Source page: https://510kreport.com/device/K973468
Methodology: https://510kreport.com/methodology