# K992715: Neuro Urodynamic Suite, Model 9032E0101

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Feb 28, 2000 after 200 days
- Product code: FEN (Device, Cystometric, Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.1620
- 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 K944547 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944547: Dantec Keypoint, Mckenna & Cuneo (1995) Summary page 1.

## Indications for use
The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests. The Duet with Neuro Urodynamic Suite is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K992715
Methodology: https://510kreport.com/methodology