# K190022: SafeBreath Filter Mouthpiece

- Pathway: 510(k) (Traditional)
- Applicant: MD Diagnostics Limited
- Decided: Sep 25, 2019 after 264 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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 K914272 (1992). 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)
- K973314: Spirosafe Filter, Micro Direct, Inc. (1997) Summary page 4.

## Indications for use
To filter possible bacteria and viruses from the patient exhalation, for use with carbon monoxide monitors. For use by healthcare professionals only.

Source page: https://510kreport.com/device/K190022
Methodology: https://510kreport.com/methodology