# K980384: Trip Tonometry Catheter, 18F

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: May 1, 1998 after 88 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
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, 18F is used for the determination of regional PCO; (PrCO,) and intrataucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter built into the device serve as a means of connecting the catheter to the TONOCAP™ monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. Since it incorporates a vented gastric sump it is also used for feeding and/or decompression or aspiration of the contents of the stomach. 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/K980384
Methodology: https://510kreport.com/methodology