# K970595: Circon Endotek OM-4 H2O Cystometry Pump

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Oct 24, 1997 after 248 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 K921047 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920451: Endotek Ultra System, Surgitek (1992) Summary page 2.
- K921047: Model 8100 Urodynamics Measuring System, Browne Medical Systems, Inc. (1992) Summary page 2.
- K920992: Profile Plus Urodynamics Measuring Syst, Modified, Browne Medical Systems, Inc. (1992) Summary page 2.
- K920575: Merkur 4000, F.M. Wiest USA, Inc. (1992) Summary page 2.

## Indications for use
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques. The Circon Endotek OM-4 H,0O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.

Source page: https://510kreport.com/device/K970595
Methodology: https://510kreport.com/methodology