510(k) · Cleared
ClearedCheckpoint
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 Oct 28, 2009 as substantially equivalent to K061365 (Ndi Medical, LLC, 2006) after a 91-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 28, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905045 (1991). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK905045 Nerve Locator/StimulatorAaron Medical Industries · 1991
- 1 generation backK061365 Checkpoint with Accustim TechnologyNdi Medical, LLC · 2006
- This deviceK092292 CheckpointNdi Medical, LLC · 2009
- Descendant · cites it directly · 1 of its ownK150005 Checkpoint, Checkpoint Head & NeckNdi Medical, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK253536 Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK212355 Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian…Checkpoint Surgical · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK200886 StimSiteAllotrope Medical, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K150005Checkpoint, Checkpoint Head & NeckNdi Medical, LLC · 2015 · cites it directly1descendant
- K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc. · 2026 · 2 generations on0descendants
- K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative…Checkpoint Surgical · 2021 · cites it directly0descendants
- K200886StimSiteAllotrope Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905045 | Nerve Locator/Stimulator | Aaron Medical Industries | 1991 | — |
| −1 | K061365 | Checkpoint with Accustim Technology | Ndi Medical, LLC | 2006 | — |
| 0 (this device) | K092292 | Checkpoint | Ndi Medical, LLC | 2009 | — |
| +1 | K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | 2015 | — |
| +2 | K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026 | — |
| +1 | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian… | Checkpoint Surgical | 2021 | 2 |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K061365 | Checkpoint with Accustim TechnologySummary page 1…kpoint® Common/Usual Name: Surgical Nerve Stimulator/Locator Classification Name: Surgical Nerve Stimulator/Locator 3. PREDICATE DEVICE K061365 - Checkpoint Surgical Nerve Stimulator/Locator 4. DEVICE DESCRIPTION The Checkpoint® is a small handheld device us… | 2006 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150005 (Ndi Medical, LLC, 2015) 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. 2009, 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?
The Checkpoint® is a single-use sterile 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. The Checkpoint is available for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092292: Checkpoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092292
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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