# K992181: Trip Tonometry Catheter, 8F

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Aug 24, 1999 after 57 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The TRIP® Tonometry Catheter, 8F is used for the determination of regional PCO; (PrCQO,) and intramucosal pH (pHi) of the gastric or colonic mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer). The sampling line and biofitter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and /or decompression or aspiration of the contents of the stomach or colon. It is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia.

Source page: https://510kreport.com/device/K992181
Methodology: https://510kreport.com/methodology