510(k) · Cleared
ClearedEvala Nerve Stimulator (EPNR002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epineuron Technologies, Inc. · ETN Stimulator, Nerve
Cleared on Feb 27, 2026 as substantially equivalent to K150005 (Ndi Medical, LLC, 2015) after a 106-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Feb 27, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K905045 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK905045 Nerve Locator/StimulatorAaron Medical Industries · 1991
- 3 generations backK061365 Checkpoint with Accustim TechnologyNdi Medical, LLC · 2006
- 2 generations backK092292 CheckpointNdi Medical, LLC · 2009
- 1 generation backK150005 Checkpoint, Checkpoint Head & NeckNdi Medical, LLC · 2015
- This deviceK253536 Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905045 | Nerve Locator/Stimulator | Aaron Medical Industries | 1991 | — |
| −3 | K061365 | Checkpoint with Accustim Technology | Ndi Medical, LLC | 2006 | — |
| −2 | K092292 | Checkpoint | Ndi Medical, LLC | 2009 | — |
| −1 | K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | 2015 | — |
| 0 (this device) | K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K150005 | Checkpoint, Checkpoint Head & Neck | 2015 |
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 11.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Evala is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253536: Evala Nerve Stimulator (EPNR002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253536
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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