# K042655: Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456

- Pathway: 510(k) (Traditional)
- Applicant: Respironics New Jersey, Inc.
- Decided: Oct 13, 2004 after 15 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: 2 generations back to K914251 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992643: Model Irc 1001 Aerosol Compressor, Invacare Corp. (1999) Summary page 1.

## Indications for use
This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.

Source page: https://510kreport.com/device/K042655
Methodology: https://510kreport.com/methodology