510(k) · Cleared
ClearedGuardianTM Burr Hole Cover System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · GXR Cover, Burr Hole
Cleared on Jul 20, 2018 as substantially equivalent to K152342 (St Jude Medical, 2016) after a 56-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jul 20, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001096 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001096 Burr Hole Cover, Model XXImage-Guided Neurologics, Inc. · 2000 · Recalled
- 3 generations backK123163 Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013
- 2 generations backK141368 Neuropace Burr Hole CoverNeuroPace, Inc. · 2014
- 1 generation backK152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016
- This deviceK181382 GuardianTM Burr Hole Cover SystemSt Jude Medical · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001096 | Burr Hole Cover, Model XX | Image-Guided Neurologics, Inc. | 2000 | 1 |
| −3 | K123163 | Neuropace Burr Hole Cover Model 8110 | NeuroPace, Inc. | 2013 | — |
| −2 | K141368 | Neuropace Burr Hole Cover | NeuroPace, Inc. | 2014 | — |
| −1 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016 | — |
| 0 (this device) | K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSummary page 4…M Burr Hole Cover System Common Name: Cover, Burr Hole Regulatory Class II Classification Name: 882.5250 Burr Hole Cover Predicate Device: K152342: Guardian™ Burr Hole Cover System Purpose of Submission This Abbreviated 510(k) premarket notification is submitted to… | 2016 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Guardian burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) burr hole cover for the skull. It can also be used to secure a lead with a 1.29-mm (0.051-in) or 1.39-mm (0.055-in) diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181382: GuardianTM Burr Hole Cover System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181382
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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