# K261633: VisuBreath

- Pathway: 510(k) (Traditional)
- Applicant: Affirm Medical Technologies II, LLC
- Decided: Jul 14, 2026 after 57 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894053 (1989). 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)
- K133540: Flocap, Maxtec, Inc. (2014) Summary page 5.

## Indications for use
The VisuBreath is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. The VisuBreath has a visual indicator to visually detect the end of exhalation. For use up to 24 hours. For patients greater than 15 kg (33 Ibs). Environment of Use - hospital, sub-acute, pre-hospital, transport.

Source page: https://510kreport.com/device/K261633
Methodology: https://510kreport.com/methodology