# K042572: Kendall CO2NFIRM Now CO2 Detector

- Pathway: 510(k) (Traditional)
- Applicant: Kendall
- Decided: Nov 5, 2004 after 45 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 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)
- K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector, Fenem, Inc. (1989) Summary page 1.
- K944400: Pedi-Cap, Nellcor, Inc. (1994) Summary page 1.

## Most influential descendants
- K212316: DoubleChek DC-1001 (2022), 0 descendants of its own

## Indications for use
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.

Source page: https://510kreport.com/device/K042572
Methodology: https://510kreport.com/methodology