# K133540: Flocap

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, Inc.
- Decided: Mar 28, 2014 after 130 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: 2 generations back to K894053 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370, Mercury Medical (2002) Summary page 1.

## Most influential descendants
- K261633: VisuBreath (2026), 0 descendants of its own

## Indications for use
The FLOCAP 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 FLOCAP has a visual indicator to visually detect the end of exhalation. For use up to 24 hours. For patients greater than 15 kg (33 lbs.) Environment of use — hospital, sub-acute, pre-hospital, transport

Source page: https://510kreport.com/device/K133540
Methodology: https://510kreport.com/methodology