# K992713: Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Nov 10, 1999 after 90 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K946322: Polygram Software, Synectics Medical, Inc. (1995) Summary page 1.
- K961070: Esophageal Manometry Analysis Module, Synectics Medical, Inc. (1996) Summary page 1.

## Indications for use
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.

Source page: https://510kreport.com/device/K992713
Methodology: https://510kreport.com/methodology