# K961070: Esophageal Manometry Analysis Module

- Pathway: 510(k) (Traditional)
- Applicant: Synectics Medical, Inc.
- Decided: Jun 11, 1996 after 85 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K992713: Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101 (1999), 0 descendants of its own

## Indications for use
The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract. The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.

Source page: https://510kreport.com/device/K961070
Methodology: https://510kreport.com/methodology