510(k) · Cleared
Recalled · Class II · 2024DURAFORM Dural Graft Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GXQ Dura Substitute
Cleared on Oct 30, 2015 as substantially equivalent to K033395 (Codman & Shurtleff, Inc., 2004) after a 60-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Oct 30, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950956 (1995). 9 ancestors in all, the oldest K910555 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 3 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 2 generations backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- 1 generation backK033395 Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473…Codman & Shurtleff, Inc. · 2004
- This deviceK152481 DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −3 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −2 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| −1 | K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474… | Codman & Shurtleff, Inc. | 2004 | — |
| 0 (this device) | K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 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 |
|---|---|---|---|
| * | K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…Summary page 4…II Product Code GXQ III. Predicate The predicate device for this submission is the CODMAN Dural Graft Device Implant (K033395), which was cleared on February 25, 2004. IV. Device The DURAFORM Dural Graft Implant is a single use, sterile collagen D… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2024 | Class II | Z-0262-2025 | Nonconforming Material/Component | Out of specification endotoxin levels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K033395.
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152481: DURAFORM Dural Graft Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152481
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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