510(k) · Cleared
ClearedUropower
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · EXY Uroflowmeter
Cleared on Aug 26, 2003 as substantially equivalent to K894968 (Eutectic Electronics, Inc., 1989) after a 375-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 26, 2003
- Review
- 375 days
- Class
- Class II
- Product code
- EXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894968 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK894968 UltracompactEutectic Electronics, Inc. · 1989
- This deviceK022721 UropowerW.O.M. World of Medicine AG · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894968 | Ultracompact | Eutectic Electronics, Inc. | 1989 | — |
| 0 (this device) | K022721 | Uropower | W.O.M. World of Medicine AG | 2003 | — |
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 EXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K894968 | UltracompactSummary page 1…Class 11. This device is described in 2 1 C.F.R. 4 876.1800. The product code for the device is EXY. IV. Predicate Devices: 0 Ultracompact (K894968) from Eutectic Electronics, Inc. V. Intended Use: The Uropower is a urine flow and volume measuring system intended… | 1989 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EXY devicesEXY Uroflowmeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EXY
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · EXY
Too few EXY 510(k)s in any year since 2007 to give a median.
Recalls per year · EXY
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EXY
No MAUDE report names EXY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine flow and volume of men during the course of normal urination. The device is also intended to be used by health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022721: Uropower.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022721
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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