510(k) · Cleared
ClearedFremap Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corporation · ETN Stimulator, Nerve
Cleared on May 6, 2016 as substantially equivalent to K133348 (Spes Medica Srl, 2014) and 1 other predicate after a 224-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- May 6, 2016
- Review
- 224 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K923056 (1992). 21 ancestors in all, the oldest K895676 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 7 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 6 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 5 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 4 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 3 generations backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 2 generations backK112426 Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd. · 2012
- 1 generation backK133348 Stim ProbeSpes Medica Srl · 2014 · Recalled
- This deviceK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −7 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −6 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −5 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −4 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −3 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| −2 | K112426 | Xian Friendship Disposable Nerve Stimulator Probes | Xian Friendship Medical Electronics Co., Ltd. | 2012 | — |
| −1 | K133348 | Stim Probe | Spes Medica Srl | 2014 | 1 |
| 0 (this device) | K152769 | Fremap Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 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 |
|---|---|---|---|
| * | K133348 | Stim ProbeSummary page 4…21 CFR 882.1310 Cortical Electrode Product Code: GYC Class II Predicate Devices: K133348 IOM Stimulator Probes (Primary Predicate) K944061 Cueva Cranial Nerve Electrode Refe… | 2014 |
| * | K944061 | Cueva Cranial Nerve ElectrodeSummary page 4…GYC Class II Predicate Devices: K133348 IOM Stimulator Probes (Primary Predicate) K944061 Cueva Cranial Nerve Electrode Reference Device: K053363 Subdural Electrode 5.1 Product Description Th… | 1995 |
| † | K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… | 2006 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 21 ancestors have a recall of any class.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 FREMAP Cranial Nerve Electrodes are designed for intraoperative (=< 10 hours) monitoring/recording from and
stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when connected
to the MEE-1000A or MEE-2000 Neural Function Measuring System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152769: Fremap Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152769
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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