510(k) · Cleared
ClearedStimulating Bur Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · ETN Stimulator, Nerve
Cleared on Nov 29, 2006 as substantially equivalent to K992869 (Xomed, Inc., 1999) after a 28-day review. Its family tree reaches back 2 generations to 1998. 1 of the 427 devices in its family, counting itself, has a Class I recall. 424 later devices descend from it.
- Decided
- Nov 29, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980148 (1998). 424 later devices descend from it, 2 citing it directly. 1 of the 427 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK980148 Neurosign 800, 8 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1998
- 1 generation backK992869 Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 1999
- This deviceK063305 Stimulating Bur GuardMedtronic Xomed, Inc. · 2006
- Descendant · cites it directly · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 424 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 424 · See all- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · cites it directly418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 2 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on396descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · 3 generations on246descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980148 | Neurosign 800, 8 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1998 | — |
| −1 | K992869 | Xomed Ball-Tip Monopolar Stimulator Probe | Xomed, Inc. | 1999 | — |
| 0 (this device) | K063305 | Stimulating Bur Guard | Medtronic Xomed, Inc. | 2006 | — |
| +1 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +2 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +2 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +3 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 28 | 0 |
| 2020 | 22 | 0 |
| 2021 | 41 | 1 |
| 2022 | 46 | 0 |
| 2023 | 62 | 0 |
| 2024 | 59 | 0 |
| 2025 | 61 | 0 |
| 2026 | 54 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeSummary page 1…oduct Code HWE, Class 1) Marketed device claiming equivalence to: The Stimulating Bur Guard is equivalent to the Medtronic Xomed Monopolar Stimulator Probe, K992869. The guard is also an accessory to the XPS 3000 Drill System covered under K041523. Device Description The Stimulat… | 1999 |
What descends from it? (424)
See all 4242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111520 (Medtronic Xomed, Inc., 2011) has gone furthest, with 418 descendants of its own.
- 6 other devices also cite its predicate K992869.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063305: Stimulating Bur Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063305
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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