# K962085: Salter Labs 8990 Series Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Aug 26, 1996 after 89 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). 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)
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 1.

## Indications for use
The Model 8990 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as tubing which are industry standard devices used with nebulizers.

Source page: https://510kreport.com/device/K962085
Methodology: https://510kreport.com/methodology