# K972439: Anorectal Manometry Analysis Module

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic-Synectics
- Decided: Sep 23, 1997 after 85 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: 1 generation back to K872712 (1988). 1 ancestor in all.
1 later device descends 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)
- K872712: PC Polygraf, Synectics-Dantec (1988) Summary page 1.

## Most influential descendants
- K991389: Anorectal Manometry Suite, Model 9032S0201 (1999), 0 descendants of its own

## Indications for use
The Anorectal Analysis Module is a suflware program that has been designed to analyse pressure duta recorded from the lower gastrointestinal tract in pediatric and adult populations.

Source page: https://510kreport.com/device/K972439
Methodology: https://510kreport.com/methodology