510(k) · Cleared
ClearedEARP Nerve Cuff Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, Inc. · ETN Stimulator, Nerve
Cleared on Oct 6, 2023 as substantially equivalent to K103128 (Cadwell Lab, Inc., 2011) and 1 other predicate after a 192-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Oct 6, 2023
- Review
- 192 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K923056 (1992). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 5 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 4 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 3 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 2 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 1 generation backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- This deviceK230853 EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK241917 EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −5 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −4 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −3 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −2 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −1 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| 0 (this device) | K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023 | — |
| +1 | K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Summary page 6…ctrode is substantially equivalent to the following predicates: 510(k) Number Manufacturer & Predicate Device Name Predicate K103128 Cadwell Lab Disposable Stimulator Probes Primary K944061 Ad-Tech Medical Cueva… | 2011 |
| * | K944061 | Cueva Cranial Nerve ElectrodeSummary page 6…& Predicate Device Name Predicate K103128 Cadwell Lab Disposable Stimulator Probes Primary K944061 Ad-Tech Medical Cueva Cranial Nerve Electrode Additional SUMMARY OF NON-CLINICAL TESTING No FDA p… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241917 | EARP Nerve Cuff Electrode | 2024 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K241917 (Retropsoas Technologies, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K103128.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230853: EARP Nerve Cuff Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230853
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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