# K983403: Salter Labs Nebulizer Exhalation Aerosol Filter

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Dec 17, 1998 after 81 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 K926455 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926455: Pari Filter/Valve Set, Paul Ritzau Pari-Werk GmbH (1993) Summary page 1.

## Most influential descendants
- K220145: Monaghan medical filtered mouthpiece kit (2023), 0 descendants of its own
- K992986: Salter Labs Single Patient Use Exhalation Aerosol Filter (1999), 0 descendants of its own

## 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/K983403
Methodology: https://510kreport.com/methodology