510(k) · Cleared
ClearedStimSite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allotrope Medical, Inc. · ETN Stimulator, Nerve
Cleared on Nov 10, 2020 as substantially equivalent to K993436 (Uromed Corp., 2000) and 1 other predicate after a 222-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Nov 10, 2020
- Review
- 222 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K844216 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK844216 Grass Model NL Facial Nerve Locator & MonitorGrass Instrument Co. · 1985
- 2 generations backK970971 Uro Med Nerve StimulatorUromed Corp. · 1997
- 1 generation backK993436 Cavermap Surgical AidUromed Corp. · 2000 · Recalled
- This deviceK200886 StimSiteAllotrope Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844216 | Grass Model NL Facial Nerve Locator & Monitor | Grass Instrument Co. | 1985 | — |
| −2 | K970971 | Uro Med Nerve Stimulator | Uromed Corp. | 1997 | — |
| −1 | K993436 | Cavermap Surgical Aid | Uromed Corp. | 2000 | 1 |
| 0 (this device) | K200886 | StimSite | Allotrope Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993436 | Cavermap Surgical AidSummary page 4…The StimSite is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K993436 UroMed CaverMap Surgical Aid / UroMed Corp. K092292 Checkpoint / NDI Medical LL… | 2000 |
| * | K092292 | CheckpointSummary page 4…Predicate Device Name / Manufacturer Primary Predicate K993436 UroMed CaverMap Surgical Aid / UroMed Corp. K092292 Checkpoint / NDI Medical LLC The predicate devices have not been subject to a design related recall. DEVICE DESCRIPT… | 2009 |
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?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.
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/K200886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200886: StimSite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200886
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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