510(k) · Cleared
Recalled · Class II · 2013Dura-Guard - Dural Repair Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · GXQ Dura Substitute
Cleared on Jul 30, 1998 as substantially equivalent to K973706 (Bio-Vascular, Inc., 1997) after a 30-day review. Its family tree reaches back 2 generations to 1995. 13 later devices descend from it. It has been recalled once.
- Decided
- Jul 30, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950956 (1995). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 1 generation backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- This deviceK982282 Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · 2 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- Descendant · 2 generations on · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
- Descendant · 2 generations on · 2 of its ownK161370 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK113071 Synthecel Dura Replacement DevicesSynthes · 2012 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · cites it directly7descendants
- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 2 generations on5descendants
- K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · 2 generations on3descendants
- K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016 · 2 generations on2descendants
- K113071Synthecel Dura Replacement DevicesSynthes · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −1 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| 0 (this device) | K982282 | Dura-Guard - Dural Repair Patch | Bio-Vascular, Inc. | 1998 | — |
| +1 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +2 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| +2 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
| +2 | K161370 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2016 | 1 |
| +1 | K113071 | Synthecel Dura Replacement Devices | Synthes | 2012 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 GXQ? 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 GXQ device
- #1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 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 |
|---|---|---|---|
| * | K973706 | Dura-Guard-Dural Repair PatchSummary page 1…Phone: (612) 603-3700 Date Prepared: June 29, 1998 Common or Usual Name: Dura-Guard® Device Classification Name: Dural Repair Patch Substantial Equivalence: Dura-Guard K973706 Device Description: Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde. S… | 1997 |
What descends from it? (13)
See all 134 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2013 | Class II | Z-0339-2014 | Packaging change control | Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041000 (Medtronic Neurosurgery, 2004) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K973706.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXQ
94in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXQ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXQ
61in 2025
MAUDE reports naming product code GXQ, 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 | 55 |
| 2008 | 0 | — | 0 | 43 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 1 | — | 6 | 36 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 38 |
| 2013 | 3 | 181 | 1 | 72 |
| 2014 | 1 | — | 0 | 18 |
| 2015 | 3 | 214 | 0 | 62 |
| 2016 | 3 | 94 | 0 | 58 |
| 2017 | 2 | — | 0 | 57 |
| 2018 | 0 | — | 0 | 94 |
| 2019 | 1 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 2 | 76 |
| 2022 | 1 | — | 0 | 59 |
| 2023 | 1 | — | 0 | 109 |
| 2024 | 0 | — | 2 | 55 |
| 2025 | 2 | — | 0 | 61 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use as a dural substitute for the closure of dura mater during neurosurgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982282: Dura-Guard - Dural Repair Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982282
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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