510(k) · Cleared
ClearedUro Med Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uromed Corp. · ETN Stimulator, Nerve
Cleared on Oct 27, 1997 as substantially equivalent to K844216 (Grass Instrument Co., 1985) after a 224-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Oct 27, 1997
- Review
- 224 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844216 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK844216 Grass Model NL Facial Nerve Locator & MonitorGrass Instrument Co. · 1985
- This deviceK970971 Uro Med Nerve StimulatorUromed Corp. · 1997
- Descendant · cites it directly · 1 of its ownK993436 Cavermap Surgical AidUromed Corp. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK200886 StimSiteAllotrope Medical, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844216 | Grass Model NL Facial Nerve Locator & Monitor | Grass Instrument Co. | 1985 | — |
| 0 (this device) | K970971 | Uro Med Nerve Stimulator | Uromed Corp. | 1997 | — |
| +1 | K993436 | Cavermap Surgical Aid | Uromed Corp. | 2000 | 1 |
| +2 | K200886 | StimSite | Allotrope Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2020 | 1 | 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 ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844216 | Grass Model NL Facial Nerve Locator & MonitorSummary page 1…imulator/Locator Classification Name(s): 21 CFR § 874.1820 Surgical Nerve Stimulator/Locator Predicate Devices used for Substantial Equivalence Grass Nerve Stimulator K844216 Brown Nocturnal Penile Tumescence Monitor K830221 Intended Use The Urovations Nerve Stimulator is intended to provide electrical… | 1985 |
| Kept off the family tree | K830221 | FDA’s K830221 is Bedside N.P.T. 9900 - Printer 9800 Our OCR of the scanned summary read K830221, FDA’s number for Bedside N.P.T. 9900 - Printer 9800 (Browne Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Brown Nocturnal Penile Tumescence Monitor”. Kept off the family tree. Summary page 1…874.1820 Surgical Nerve Stimulator/Locator Predicate Devices used for Substantial Equivalence Grass Nerve Stimulator K844216 Brown Nocturnal Penile Tumescence Monitor K830221 Intended Use The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify ne… | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993436 | Cavermap Surgical Aid | 2000 | 1 |
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.
- Of its descendants, K993436 (Uromed Corp., 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon’s expertise in mapping out the vascular bundles. Each surgeon’s skill determines whether these nerves are spared regardless of any aid.
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/K970971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970971: Uro Med Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970971
Report an extraction error
Are you the manufacturer?
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