510(k) · Cleared
ClearedGuardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
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 Jun 9, 2016 as substantially equivalent to K123163 (NeuroPace, Inc., 2013) and 1 other predicate after a 295-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jun 9, 2016
- Review
- 295 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001096 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001096 Burr Hole Cover, Model XXImage-Guided Neurologics, Inc. · 2000 · Recalled
- 2 generations backK123163 Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013
- 1 generation backK141368 Neuropace Burr Hole CoverNeuroPace, Inc. · 2014
- This deviceK152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical · 2016
- Descendant · cites it directly · 0 of its ownK181382 GuardianTM Burr Hole Cover SystemSt Jude Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K181382GuardianTM Burr Hole Cover SystemSt Jude Medical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001096 | Burr Hole Cover, Model XX | Image-Guided Neurologics, Inc. | 2000 | 1 |
| −2 | K123163 | Neuropace Burr Hole Cover Model 8110 | NeuroPace, Inc. | 2013 | — |
| −1 | K141368 | Neuropace Burr Hole Cover | NeuroPace, Inc. | 2014 | — |
| 0 (this device) | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016 | — |
| +1 | K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K123163 | Neuropace Burr Hole Cover Model 8110Summary page 4…over System Common Cover, Burr Hole Name: Class II Classification 882.5250 Burr Hole Cover Name: Predicate NeuroPace, Inc. Burr Hole Cover (K123163) and (K141368) Device: Device The Guardian™ burr hole cover system consists of three main features: base, clip, and Des… | 2013 |
| * | K141368 | Neuropace Burr Hole CoverSummary page 4…mmon Cover, Burr Hole Name: Class II Classification 882.5250 Burr Hole Cover Name: Predicate NeuroPace, Inc. Burr Hole Cover (K123163) and (K141368) Device: Device The Guardian™ burr hole cover system consists of three main features: base, clip, and Description:… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181382 | GuardianTM Burr Hole Cover System | 2018 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181382 (St Jude Medical, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123163.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 during cranial surgery as an implantable 14 mm 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/K152342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152342: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152342
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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