510(k) · Cleared
ClearedCircon Endotek OM-4 H2O Cystometry Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Video · FEN Device, Cystometric, Hydraulic
Cleared on Oct 24, 1997 as substantially equivalent to K920451 (Surgitek, 1992) and 3 other predicates after a 248-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 24, 1997
- Review
- 248 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K921047 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK921047 Model 8100 Urodynamics Measuring SystemBrowne Medical Systems, Inc. · 1992
- This deviceK970595 Circon Endotek OM-4 H2O Cystometry PumpCircon Video · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921047 | Model 8100 Urodynamics Measuring System | Browne Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K970595 | Circon Endotek OM-4 H2O Cystometry Pump | Circon Video | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
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 K212830 CT3000Proscore 2.8 · 2 generations · no Class I recall
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920451 | Endotek Ultra SystemSummary page 2…ge BSI Package Drop Test NSTA Marketed Devices Used for Substantial Equivalence Manufacturer Model No. Description 510(k) No. Circon Endotek Ultra System Cystometric K920451 Measuring System Browne MiniPro 8100 Cystometric K921047 Measuring System Browne Profile Plus Cystometric K920992 Measuring Sys… | 1992 |
| * | K921047 | Model 8100 Urodynamics Measuring SystemSummary page 2…Substantial Equivalence Manufacturer Model No. Description 510(k) No. Circon Endotek Ultra System Cystometric K920451 Measuring System Browne MiniPro 8100 Cystometric K921047 Measuring System Browne Profile Plus Cystometric K920992 Measuring System WIEST MERKUR 4000 | Cystometric K920575 Measuring Sys… | 1992 |
| * | K920992 | Profile Plus Urodynamics Measuring Syst, ModifiedSummary page 2…n 510(k) No. Circon Endotek Ultra System Cystometric K920451 Measuring System Browne MiniPro 8100 Cystometric K921047 Measuring System Browne Profile Plus Cystometric K920992 Measuring System WIEST MERKUR 4000 | Cystometric K920575 Measuring System Device Description and Intended Use of the Marketed D… | 1992 |
| * | K920575 | Merkur 4000Summary page 2…451 Measuring System Browne MiniPro 8100 Cystometric K921047 Measuring System Browne Profile Plus Cystometric K920992 Measuring System WIEST MERKUR 4000 | Cystometric K920575 Measuring System Device Description and Intended Use of the Marketed Device The Circon Endotek OM-4 H,O Cystometry Pump is a pe… | 1992 |
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 4 ancestors has a recall.
How does its category compare?
All FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEN
1in 2021
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
MAUDE reports naming product code FEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970595: Circon Endotek OM-4 H2O Cystometry Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970595
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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