# K112824: Quality Life Technologies Compressor Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Quality Life Technologies Co;Ltd
- Decided: Jun 21, 2012 after 267 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 K870027 (1987). 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)
- K931015: Devilbiss Model 4650 Compressor Neubulizer, Devilbiss Health Care, Inc. (1993) Summary page 1.
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 1.
- K052438: Emg Handle Nebulizer NB02 Series, Emg Technology Co., Ltd. (2006) Summary page 2.

## Indications for use
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patients respiratory tract for the treatment of respiratory disorders. The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed. The intended environment for use of the product is in the patient's home on the order of a physician.

Source page: https://510kreport.com/device/K112824
Methodology: https://510kreport.com/methodology