510(k) Report

510(k) · Cleared

Cleared

Durasis Dural Substitute

K031850510(k) TraditionalCleared Sep 8, 200384-day reviewClass II21 CFR 882.5910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Biotech, Inc. · GXQ Dura Substitute

Cleared on Sep 8, 2003 as substantially equivalent to K950956 (Bio-Vascular, Inc., 1995) and 4 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.

Decided
Sep 8, 2003
Review
84 days
Class
Class II
Product code
GXQ
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K921895 (1992). 14 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors1997: 3 other ancestors1996: 1 other ancestor1983: 1 other ancestor2016: 1 descendant cleared2013: 1 descendant clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920
  1. Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
  4. This deviceK031850 Durasis Dural SubstituteCook Biotech, Inc. · 2003
  5. Descendant · cites it directly · 0 of its ownK160869 Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's…Cook Biotech Incorporated · 2016 · Recalled
  6. Descendant · cites it directly · 0 of its ownK131015 Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated · 2016 · cites it directly0descendants
  • K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−2K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−1K980431SurgisisCook Biotech, Inc.1998—
0 (this device)K031850Durasis Dural SubstituteCook Biotech, Inc.2003—
+1K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated20161
+1K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199220
199520
199610
199730
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
FIG. 1 — Lineage of K031850, 1992–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K950956Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute
Summary page 1
…for use as a dura substitute for repairing dura mater. The device is intended for one-time use. Predicate Devices: Predicate devices are Dura-Guard@Dural Repair Patch (K950956), manufactured by Bio-Vascular, Inc., Tutoplast@Processed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODM…
Bio-Vascular, Inc.1995—
*K910555Tutoplast Dura
Summary page 1
…for one-time use. Predicate Devices: Predicate devices are Dura-Guard@Dural Repair Patch (K950956), manufactured by Bio-Vascular, Inc., Tutoplast@Processed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODMAN ETHISORBTMDura Patch (K991413), marketed by Johnson & Johnson, Surgisis@Sof…
Pfrimmer-Viggo GmbH & Co.1992—
*K991413Codman Ethisorb Dura Patch
Summary page 1
…Patch (K950956), manufactured by Bio-Vascular, Inc., Tutoplast@Processed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODMAN ETHISORBTMDura Patch (K991413), marketed by Johnson & Johnson, Surgisis@Soft Tissue Graft (K980431), manufactured by Cook Biotech Incorporated, and DuraGen Dur…
Johnson & Johnson Professionals, Inc.2000—
*K980431Surgisis
Summary page 1
…ssed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODMAN ETHISORBTMDura Patch (K991413), marketed by Johnson & Johnson, Surgisis@Soft Tissue Graft (K980431), manufactured by Cook Biotech Incorporated, and DuraGen Dural Matrix (K982180) manufactured by Integra Neurosciences. Device De…
Cook Biotech, Inc.1998—
*K982180Duragen Dural Graft Matrix
Summary page 1
…ETHISORBTMDura Patch (K991413), marketed by Johnson & Johnson, Surgisis@Soft Tissue Graft (K980431), manufactured by Cook Biotech Incorporated, and DuraGen Dural Matrix (K982180) manufactured by Integra Neurosciences. Device Description: Durasis@Dural Substitute is manufactured from porcine small intestin…
Integra Lifesciences Corp.19991

Also cleared against K950956: 5 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated20160
K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130

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 11 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K160869 (Cook Biotech Incorporated, 2016) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K950956.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXQ

2in 2025

2007: 22010: 12012: 22013: 32014: 12015: 32016: 32017: 22019: 12022: 12023: 12025: 2
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXQ

94in 2016

2013: 181 days median2015: 214 days median2016: 94 days median
2007high 214 (2015) · low 94 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXQ

2in 2024

2010: 62013: 12021: 22024: 2
2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXQ

61in 2025

2007: 552008: 432009: 462010: 362011: 312012: 382013: 722014: 182015: 622016: 582017: 572018: 942019: 632020: 1142021: 762022: 592023: 1092024: 552025: 61
2007high 114 (2020) · low 18 (2014)2025

MAUDE reports naming product code GXQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—055
20080—043
20090—046
20101—636
20110—031
20122—038
20133181172
20141—018
20153214062
2016394058
20172—057
20180—094
20191—063
20200—0114
20210—276
20221—059
20231—0109
20240—255
20252—061
20260—0—

What is it indicated for?

Durasis' Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.

Indications for use as stated in the FDA summary.

Also cleared against K950956

5 other devices cite the same predicate.

  • K132850Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DMRti Surgical, Inc. · 2014
  • K113071Synthecel Dura Replacement DevicesSynthes · 20125 recalls
  • K040888Duramatrix Collagen Dura Substitute MembraneCollagen Matrix, Inc. · 2004
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K973706Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997

More from Cook Biotech, Inc.

31 FDA decisions under this applicant name. See the company

  • K133306Sis Hernia GraftCook Biotech, Inc. · 2014
  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall
  • K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013
  • K111695Hybrid GraftCook Biotech, Inc. · 2012
  • K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011

Recent decisions in GXQ

The GXQ category page

  • K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025
  • K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc. · 2025
  • K223445ArtiFasciaNurami Medical, Ltd. · 2023
  • K212943SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
  • K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. · 2019

https://510kreport.com/device/K031850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031850: Durasis Dural Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031850

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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