# K212316: DoubleChek DC-1001

- Pathway: 510(k) (Traditional)
- Applicant: Nasogastric Feeding Solutions, Ltd.
- Decided: Sep 30, 2022 after 431 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: 2 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)
- K042572: Kendall CO2NFIRM Now CO2 Detector, Kendall (2004) Summary page 4.

## Indications for use
The DoubleCHEK is indicated for use with an initially placed or an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube. The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.

Source page: https://510kreport.com/device/K212316
Methodology: https://510kreport.com/methodology