# K220145: Monaghan medical filtered mouthpiece kit

- Pathway: 510(k) (Traditional)
- Applicant: Monaghan Medical Corporation
- Decided: Aug 24, 2023 after 582 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). 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)
- K983403: Salter Labs Nebulizer Exhalation Aerosol Filter, Salter Labs (1998) Summary page 4.
- K080926: Aeroeclipse Durable Breath Actuated Nebulizer, Trudell Medical Intl. (2008) Summary page 4.

## Indications for use
The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home, or clinic environment with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.

Source page: https://510kreport.com/device/K220145
Methodology: https://510kreport.com/methodology