510(k) · Cleared
ClearedNeuropace Burr Hole Cover Model 8110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NeuroPace, Inc. · GXR Cover, Burr Hole
Cleared on Jan 18, 2013 as substantially equivalent to K001096 (Image-Guided Neurologics, Inc., 2000) after a 101-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 101 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001096 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001096 Burr Hole Cover, Model XXImage-Guided Neurologics, Inc. · 2000 · Recalled
- This deviceK123163 Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK141368 Neuropace Burr Hole CoverNeuroPace, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · cites it directly · 1 of its ownK152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016
- Descendant · 2 generations on · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK181382 GuardianTM Burr Hole Cover SystemSt Jude Medical · 2018
Most influential descendants
Showing 5 of 5 · See all- K141368Neuropace Burr Hole CoverNeuroPace, Inc. · 2014 · cites it directly2descendants
- K160739Cranial COVERNeos Surgery S.L · 2016 · cites it directly1descendant
- K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016 · cites it directly1descendant
- K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020 · 2 generations on0descendants
- K181382GuardianTM Burr Hole Cover SystemSt Jude Medical · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001096 | Burr Hole Cover, Model XX | Image-Guided Neurologics, Inc. | 2000 | 1 |
| 0 (this device) | K123163 | Neuropace Burr Hole Cover Model 8110 | NeuroPace, Inc. | 2013 | — |
| +1 | K141368 | Neuropace Burr Hole Cover | NeuroPace, Inc. | 2014 | — |
| +1 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +1 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016 | — |
| +2 | K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020 | — |
| +2 | K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 GXR? 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 GXR device
- #1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 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.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K141368 (NeuroPace, Inc., 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GXR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXR
116in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXR
No recall names GXR since 2007.
Adverse event reports per year · GXR
10in 2025
MAUDE reports naming product code GXR, 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 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 4 | 116 | 0 | 4 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 2 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm burr hole. Secondarily, the NeuroPace Burr Hole Cover also can be used to support a 1.3 mm indwelling lead.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123163: Neuropace Burr Hole Cover Model 8110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123163
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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