# K964522: Ellipse 4

- Pathway: 510(k) (Traditional)
- Applicant: Andromeda Medizinische Systeme GmbH
- Decided: Mar 21, 1997 after 129 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 K912071 (1991). 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)
- K920575: Merkur 4000, F.M. Wiest USA, Inc. (1992) Summary page 2.
- K912071: Space (TM) 7500, F.M. Wiest USA, Inc. (1991) Summary page 2.

## Indications for use
The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystomelry, Pressure Flow, Urethral Pressure Profile and EMG.

Source page: https://510kreport.com/device/K964522
Methodology: https://510kreport.com/methodology