# K992643: Model Irc 1001 Aerosol Compressor

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Oct 27, 1999 after 82 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 K914251 (1992). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914251: Model Irc Passport Nebulizer, Invacare Corp. (1992) Summary page 3.
- K934749: Freeway Lite Nebulizer Compressor, Medic-Aid, Ltd. (1994) Summary page 3.

## Most influential descendants
- K082878: Nevoni Classic, Model 6600-PO (2008), 0 descendants of its own
- K062952: C300 Series Air Nebulizer Compressor (2007), 0 descendants of its own
- K042655: Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 (2004), 0 descendants of its own

## Indications for use
The Invacare Model IRC 1001 Aerosol Compressor is a prescription device designed for use in the treatment of respiratory disorders, such as asthma, in a household environment. Its intended use is to provide compressed air to a nebulizer for the generation of aerosolized medications, based on a physician’s prescription. Nebulizers are used to convert liquid medication to aerosol form for delivery to a patient through inhalation.

Source page: https://510kreport.com/device/K992643
Methodology: https://510kreport.com/methodology