# K961346: PH Analysis Module

- Pathway: 510(k) (Traditional)
- Applicant: Synectics-Dantec
- Decided: Jan 29, 1997 after 320 days
- Product code: FFT (Electrode, Ph, Stomach)
- Device class: 1
- Regulation: 21 CFR 876.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K859361: EsopHogram Software (DOS environment). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K981733: Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 (1999), 1 descendant of its own
- K011471: Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober (2002), 0 descendants of its own

## Indications for use
The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

Source page: https://510kreport.com/device/K961346
Methodology: https://510kreport.com/methodology