# K102801: Phtip Disposable Isfet Catheter

- Pathway: 510(k) (Traditional)
- Applicant: E-Cath Co., Ltd.
- Decided: Oct 26, 2010 after 29 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011472 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003580: Unitip Gastrointestinal Pressure Sensor Catheter, Unisensor AG (2001) Summary page 1.
- K062222: Unitip High Resolution Catheter, Unisensor AG (2007) Summary page 1.

## Indications for use
The pHTip™ Disposable ISFET Catheter is a device used to measure intragastric and intraesophageal pH activity in the stomach or esophagus, by means of a flexible lead with ISFET pH electrodes that is introduced through the nose into the gastrointestinal tract. It is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

Source page: https://510kreport.com/device/K102801
Methodology: https://510kreport.com/methodology