510(k) · Cleared
Recalled · Class II · 2025Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Checkpoint Surgical · ETN Stimulator, Nerve
Cleared on Aug 26, 2021 as substantially equivalent to K092292 (Ndi Medical, LLC, 2009) after a 28-day review. Its family tree reaches back 3 generations to 1991. It has been recalled 2 times.
- Decided
- Aug 26, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905045 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK905045 Nerve Locator/StimulatorAaron Medical Industries · 1991
- 2 generations backK061365 Checkpoint with Accustim TechnologyNdi Medical, LLC · 2006
- 1 generation backK092292 CheckpointNdi Medical, LLC · 2009
- This deviceK212355 Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian…Checkpoint Surgical · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905045 | Nerve Locator/Stimulator | Aaron Medical Industries | 1991 | — |
| −2 | K061365 | Checkpoint with Accustim Technology | Ndi Medical, LLC | 2006 | — |
| −1 | K092292 | Checkpoint | Ndi Medical, LLC | 2009 | — |
| 0 (this device) | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian… | Checkpoint Surgical | 2021 | — |
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 |
|---|---|---|---|
| * | K092292 | CheckpointSummary page 4…turer Trade Name Product Code Submission # Checkpoint Surgical Checkpoint ETN K092292 5 Description of Device The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2025 | Class II | Z-1466-2025 | Process control | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or… |
| Feb 24, 2025 | Class II | Z-1467-2025 | Process control | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K092292.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators 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/K212355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212355: Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212355
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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