# K063449: Deluxe Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Access Point Medical, LLC
- Decided: Mar 1, 2007 after 106 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 K003344 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003344: Medical Depot Nebulizer, Model Power Neb 2, Medical Depot, Inc. (2001) Summary page 1.

## Indications for use
The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

Source page: https://510kreport.com/device/K063449
Methodology: https://510kreport.com/methodology