# K991389: Anorectal Manometry Suite, Model 9032S0201

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Jul 15, 1999 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: 2 generations back to K872712 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972439: Anorectal Manometry Analysis Module, Medtronic-Synectics (1997) Summary page 1.

## Indications for use
The Duet with Anorectal Manometry Suite is intended to measure and record the functioning of the patient’s urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes. * expanded indication for use due to the Anorectal Manometry Suite.

Source page: https://510kreport.com/device/K991389
Methodology: https://510kreport.com/methodology