# K992986: Salter Labs Single Patient Use Exhalation Aerosol Filter

- Pathway: 510(k) (Special)
- Applicant: Salter Labs
- Decided: Sep 24, 1999 after 21 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 K926455 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983403: Salter Labs Nebulizer Exhalation Aerosol Filter, Salter Labs (1998) Summary page 1.

## Indications for use
This product is indicated for use whenever the physician or healthcare professional administering or prescribing medical aerosol products to a patient with a Salter Labs nebulizer wishes to minimize the amount of medical aerosol exhaled into the air.

Source page: https://510kreport.com/device/K992986
Methodology: https://510kreport.com/methodology