510(k) · Cleared
Recalled · Class II · 2021Burr Hole Cover, Model XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image-Guided Neurologics, Inc. · GXR Cover, Burr Hole
Cleared on Oct 25, 2000 after a 204-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 25, 2000
- Review
- 204 days
- Class
- Class II
- Product code
- GXR
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK001096 Burr Hole Cover, Model XXImage-Guided Neurologics, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK123163 Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK141368 Neuropace Burr Hole CoverNeuroPace, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
- Descendant · 2 generations on · 1 of its ownK152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016
- Descendant · 3 generations on · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123163Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013 · cites it directly5descendants
- K141368Neuropace Burr Hole CoverNeuroPace, Inc. · 2014 · 2 generations on2descendants
- K160739Cranial COVERNeos Surgery S.L · 2016 · 2 generations on1descendant
- K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016 · 2 generations on1descendant
- K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001096 | Burr Hole Cover, Model XX | Image-Guided Neurologics, Inc. | 2000 | — |
| +1 | K123163 | Neuropace Burr Hole Cover Model 8110 | NeuroPace, Inc. | 2013 | — |
| +2 | K141368 | Neuropace Burr Hole Cover | NeuroPace, Inc. | 2014 | — |
| +2 | K160739 | Cranial COVER | Neos Surgery S.L | 2016 | — |
| +2 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016 | — |
| +3 | K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123163 | Neuropace Burr Hole Cover Model 8110 | 2013 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2021 | Class II | Z-2228-2021 | Process control | Excess nylon flash on the clip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123163 (NeuroPace, Inc., 2013) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K001096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001096: Burr Hole Cover, Model XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001096
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026