# K203762: Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 17, 2021 after 268 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: 1 generation back to K944400 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944400: Pedi-Cap, Nellcor, Inc. (1994) Summary page 4.

## Indications for use
Use to assist verification of tube placement during endotracheal or nasotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.

Source page: https://510kreport.com/device/K203762
Methodology: https://510kreport.com/methodology