510(k) · Cleared
ClearedCheckpoint with Accustim Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndi Medical, LLC · ETN Stimulator, Nerve
Cleared on Jul 12, 2006 as substantially equivalent to K905045 (Aaron Medical Industries, 1991) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Jul 12, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905045 (1991). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905045 Nerve Locator/StimulatorAaron Medical Industries · 1991
- This deviceK061365 Checkpoint with Accustim TechnologyNdi Medical, LLC · 2006
- Descendant · cites it directly · 4 of its ownK092292 CheckpointNdi Medical, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK150005 Checkpoint, Checkpoint Head & NeckNdi Medical, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK253536 Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK212355 Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian…Checkpoint Surgical · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK200886 StimSiteAllotrope Medical, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K092292CheckpointNdi Medical, LLC · 2009 · cites it directly4descendants
- K150005Checkpoint, Checkpoint Head & NeckNdi Medical, LLC · 2015 · 2 generations on1descendant
- K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026 · 3 generations on0descendants
- K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative…Checkpoint Surgical · 2021 · 2 generations on0descendants
- K200886StimSiteAllotrope Medical, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905045 | Nerve Locator/Stimulator | Aaron Medical Industries | 1991 | — |
| 0 (this device) | K061365 | Checkpoint with Accustim Technology | Ndi Medical, LLC | 2006 | — |
| +1 | K092292 | Checkpoint | Ndi Medical, LLC | 2009 | — |
| +2 | K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | 2015 | — |
| +3 | K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026 | — |
| +2 | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian… | Checkpoint Surgical | 2021 | 2 |
| +2 | K200886 | StimSite | Allotrope Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K905045 | Nerve Locator/StimulatorSummary page 1…EVICES * Medtronic Xomed Vari-Stim III (pre-amendment device) Medtronic Xomed (originally Concept Medical) * Aaron Neuro-Pulse (K905045), Aaron Medical * Xomed Nerve Integrity Monitor Response 2.0 and NIM2-XL (K934426) Medtronic Xomed-Tr… | 1991 |
| * | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL)Summary page 1…Xomed (originally Concept Medical) * Aaron Neuro-Pulse (K905045), Aaron Medical * Xomed Nerve Integrity Monitor Response 2.0 and NIM2-XL (K934426) Medtronic Xomed-Treace, Inc. 4. DEVICE DESCRIPTION The CheckpointTM is a small handheld device used… | 1994 |
| * | — | Medtronic Xomed Vari-Stim III Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092292 | Checkpoint | 2009 | 4 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K092292 (Ndi Medical, LLC, 2009) has gone furthest, with 4 descendants 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 CheckpointTM 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/K061365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061365: Checkpoint with Accustim Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061365
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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