510(k) · Cleared
ClearedNondisposable Stimulating Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · ETN Stimulator, Nerve
Cleared on Oct 19, 2012 as substantially equivalent to K895676 (Rln Systems, Inc., 1989) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Oct 19, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954601 (1995). 4 ancestors in all, the oldest K895676 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954601 | Nerve Locator/Monitor System Modification | Rln Systems, Inc. | 1995 | — |
| −1 | K110140 | Neurovision Nerve Locator Monitor | Neurovision Medical Products, Inc. | 2011 | — |
| 0 (this device) | K121931 | Nondisposable Stimulating Instruments | Neurovision Medical Products, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K895676 | Hemostat/Stimulator ProbeSummary page 1…Accessory Classification Name: Surgical nerve stimulator/locator, 21 CFR 874.1820 Class 11,Product Code: ETN Predicate Devices Stimulating Hemostat (K895676); Nerve Locator Monitor (K1 10140) Device Description The Stimulating Hemostat and other manual instruments are dissectors… | 1989 |
| * | K110140 | Neurovision Nerve Locator MonitorSummary page 1…me: Surgical nerve stimulator/locator, 21 CFR 874.1820 Class 11,Product Code: ETN Predicate Devices Stimulating Hemostat (K895676); Nerve Locator Monitor (K1 10140) Device Description The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and a… | 2011 |
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 17 years and passes through 2 companies; a new generation was cleared every 15.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K895676.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121931: Nondisposable Stimulating Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121931
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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