# K963330: Urodynamic Analysis Module

- Pathway: 510(k) (Traditional)
- Applicant: Synectics Medical, Inc.
- Decided: Apr 3, 1997 after 223 days
- Product code: FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PolyUro Polygram Software (DOS environment): named in the summary without a submission number

## Indications for use
The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations. The Urodynamic Analysis Module includes the following analyses: Uroflow analysis, Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

Source page: https://510kreport.com/device/K963330
Methodology: https://510kreport.com/methodology