510(k) · Cleared
ClearedHilger Dual-Stim Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wr Medical Electronics Co. · ETN Stimulator, Nerve
Cleared on Jan 5, 2007 as substantially equivalent to K895838 (Wr Medical Electronics Co., 1990) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Jan 5, 2007
- Review
- 38 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895838 (1990). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK895838 Brackmann Emg Monitoring SystemWr Medical Electronics Co. · 1990
- This deviceK063560 Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007
- Descendant · cites it directly · 2 of its ownK081742 Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK092729 Baxano Neuro Check DeviceBaxano, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895838 | Brackmann Emg Monitoring System | Wr Medical Electronics Co. | 1990 | — |
| 0 (this device) | K063560 | Hilger Dual-Stim Nerve Stimulator | Wr Medical Electronics Co. | 2007 | — |
| +1 | K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | 2008 | — |
| +2 | K092729 | Baxano Neuro Check Device | Baxano, Inc. | 2009 | — |
| +3 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K895838 | Brackmann Emg Monitoring SystemSummary page 1…Product Code: ETN, Class II Predicate Device(s): Preamendment - Hilger Facial Nerve Stimulator K895838 - Brackman EMG Monitoring System K021595 - Gyms ENT Nerve Stimulator 1.0… | 1990 |
| * | K021595 | Gyrus Ent Nerve StimulatorSummary page 1…t - Hilger Facial Nerve Stimulator K895838 - Brackman EMG Monitoring System K021595 - Gyms ENT Nerve Stimulator 1.0 Description of Device The Hilger Dual-Stim Nerve Stimulator is a self… | 2002 |
| * | — | Hilger Facial Nerve Stimulator Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | 2008 | 2 |
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, K081742 (Baxano, Inc., 2008) has gone furthest, with 2 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. 2007, 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 Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063560 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063560: Hilger Dual-Stim Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063560
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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