510(k) Report

510(k) · Cleared

Cleared

Hybrid Graft

K111695510(k) TraditionalCleared Apr 2, 2012291-day reviewClass II21 CFR 878.3300

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

Cook Biotech, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Apr 2, 2012 as substantially equivalent to K974540 (Sentron Medical, Inc., 1998) and 4 other predicates after a 291-day review. Its family tree reaches back 3 generations to 1992.

Decided
Apr 2, 2012
Review
291 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K921895 (1992). 10 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 2 other ancestors2004: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1983: 1 other ancestor1992: 1 other ancestorK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 19981980198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 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 deviceK111695 Hybrid GraftCook Biotech, Inc. · 2012
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)K111695Hybrid GraftCook Biotech, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199710
199810
200410
200620
FIG. 1 — Lineage of K111695, 1992–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FTL? 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 FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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
*K974540Sis Hernia Repair Device
Summary page 1
…le, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch…
Sentron Medical, Inc.1998—
*K062697Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft
Summary page 1
…cellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533)…
Cook Biotech, Inc.2006—
*K980431Surgisis
Summary page 3
…k Biotech Cook Biotech Cook Biotech Ethi | d | Ethi I d Incorporated Incorporated Incorporated icon, Incorporate fcon, Incorporate 510(k) Number K111695 K974540, K$62697 K980431 K061533 K033337 Intended Use To be implanted to reinforce soft tissues where weakness exists. Indications for use include the r…
Cook Biotech, Inc.1998—
*K061533Proceed Ventral Patch
Summary page 1
…icate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAP…
ETHICON, Inc.2006—
*K033337Ultrapro Mesh
Summary page 1
…e (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a…
ETHICON, Inc.2004—

Also cleared against K974540: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 20 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 10 ancestors has a recall.
  • 5 other devices also cite its predicate K974540.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

The Hybrid Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result, This graft is supplied sterile and is intended for one-time use,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K974540

5 other devices cite the same predicate.

  • K133306Sis Hernia GraftCook Biotech, Inc. · 2014
  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall
  • K020654Stratasis Sling KitCook Biotech, Inc. · 2002
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  • K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998

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
  • K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011
  • K090688Cook Urological GraftCook Biotech, Inc. · 2009

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K111695 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111695: Hybrid Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111695

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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