510(k) · Cleared
ClearedLyoplant Dura Substitute (Various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GXQ Dura Substitute
Cleared on Dec 9, 1997 after a 277-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Dec 9, 1997
- Review
- 277 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 3 citing it directly.
- This deviceK970851 Lyoplant Dura Substitute (Various)Aesculap, Inc. · 1997
- Descendant · cites it directly · 30 of its ownK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- Descendant · 2 generations on · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
- Descendant · 2 generations on · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · 3 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
- Descendant · 3 generations on · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · cites it directly30descendants
- K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · 2 generations on9descendants
- K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · 2 generations on7descendants
- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 3 generations on5descendants
- K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970851 | Lyoplant Dura Substitute (Various) | Aesculap, Inc. | 1997 | — |
| +1 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| +2 | K032693 | Duragen Plus Dural Graft Matrix | Integra Lifesciences Corp. | 2003 | 1 |
| +2 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +3 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
| +3 | K063117 | Modification to Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | — | Dura-Guard™ Dural Repair Patch Named without a submission number | |
| * | — | Peri-Guard® Pericardium Named without a submission number | |
| * | — | Neuro-Patch Dura Substitute Named without a submission number | |
| * | — | Preclude Dura Substitute Named without a submission number | |
| * | — | Dura Film Named without a submission number | |
| * | — | Tutoplast® Dura substitute Named without a submission number |
What descends from it? (31)
See all 313 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?
- Of its descendants, K982180 (Integra Lifesciences Corp., 1999) has gone furthest, with 30 descendants of its own.
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?
Lyoplant Dura Substitute presented in this submission is intended as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
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/K970851 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970851: Lyoplant Dura Substitute (Various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970851
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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