510(k) Report

510(k) · Cleared

Cleared

Ellipse 4

K964522510(k) TraditionalCleared Mar 21, 1997129-day reviewClass II21 CFR 876.1620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Andromeda Medizinische Systeme GmbH · FEN Device, Cystometric, Hydraulic

Cleared on Mar 21, 1997 as substantially equivalent to K920575 (F.M. Wiest USA, Inc., 1992) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 1991.

Decided
Mar 21, 1997
Review
129 days
Class
Class II
Product code
FEN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K912071 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestorK912071 · Space (TM) 7500 · F.M. Wiest USA, Inc. · 199119901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K912071 · Space (TM) 7500 · F.M. Wiest USA, Inc. · 19910
  1. Root · 1 generation backK912071 Space (TM) 7500F.M. Wiest USA, Inc. · 1991
  2. This deviceK964522 Ellipse 4Andromeda Medizinische Systeme GmbH · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912071Space (TM) 7500F.M. Wiest USA, Inc.1991—
0 (this device)K964522Ellipse 4Andromeda Medizinische Systeme GmbH1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
FIG. 1 — Lineage of K964522, 1991–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FEN device

  1. #1 K212830 CT3000Proscore 2.8 · 2 generations · no Class I recall
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K920575Merkur 4000
Summary page 2
…ystomelry, Pressure Flow, Urethral Pressure Profile and EMG. The Ellipse 4™ is substantially equivalent to the MERKUR™ 4000, manufactured by F. M. Wiest Medizintechnik (K920575)and to the SPACE ™ 7500 manufactured by F. M. Wiest (K 912071). Both the Eltipse 4™ and the MERKUR™ 4000 have the same intended…
F.M. Wiest USA, Inc.1992—
*K912071Space (TM) 7500
Summary page 2
…The Ellipse 4™ is substantially equivalent to the MERKUR™ 4000, manufactured by F. M. Wiest Medizintechnik (K920575)and to the SPACE ™ 7500 manufactured by F. M. Wiest (K 912071). Both the Eltipse 4™ and the MERKUR™ 4000 have the same intended use and are of very similar design. They both have a coated al…
F.M. Wiest USA, Inc.1991—

Also cleared against K920575: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K920575.

How does its category compare?

All FEN devices

FEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEN

1in 2021

2008: 22021: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEN

Too few FEN 510(k)s in any year since 2007 to give a median.

Recalls per year · FEN

No recall names FEN since 2007.

Adverse event reports per year · FEN

3in 2024

2009: 12012: 12013: 102014: 112015: 332016: 102017: 32018: 22019: 62021: 12022: 32023: 32024: 3
2007high 33 (2015) · low 0 (2007)2025

MAUDE reports naming product code FEN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—01
20100—00
20110—00
20120—01
20130—010
20140—011
20150—033
20160—010
20170—03
20180—02
20190—06
20200—00
20211—01
20220—03
20230—03
20240—03
20250—00
20260—0—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K920575

1 other device cites the same predicate.

  • K970595Circon Endotek OM-4 H2O Cystometry PumpCircon Video · 1997

Recent decisions in FEN

The FEN category page

  • K212830CT3000ProSrs Medical · 2021
  • K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
  • K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
  • K001386Accuset Sensor, Model 2000Pelvicare, Inc. · 2000
  • K992715Neuro Urodynamic Suite, Model 9032E0101Medtronic Functional Diagnostics A/S · 2000

https://510kreport.com/device/K964522 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964522: Ellipse 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964522

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026