510(k) Report

510(k) · Cleared

Cleared

Bard Extra Large Composix Kugel Hernia Patch

K061314510(k) TraditionalCleared Jun 2, 200622-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

Davol Inc., Sub. C. R. Bard, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jun 2, 2006 as substantially equivalent to K003323 (Davol, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it.

Decided
Jun 2, 2006
Review
22 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003323 (2001). 15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2015: 3 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2016: 1 descendant clearedK003323 · Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 · Davol, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants K003323 · Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 · Davol, Inc. · 2001 · recalled0
  1. Root · 1 generation backK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001 · Recalled
  2. This deviceK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
  3. Descendant · cites it directly · 14 of its ownK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled
  4. Descendant · 2 generations on · 13 of its ownK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
  5. Descendant · 2 generations on · 3 of its ownK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
  6. Descendant · 2 generations on · 3 of its ownK101920 Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011
  7. Descendant · 3 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 22012: 12013: 12014: 22015: 32016: 12019: 12025: 2
2008high 3 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all
  • K081777Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · cites it directly14descendants
  • K100229Ventrio Hernia PatchC.R. Bard, Inc. · 2010 · 2 generations on13descendants
  • K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012 · 2 generations on3descendants
  • K101920Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011 · 2 generations on3descendants
  • K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003323Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc.20013
0 (this device)K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc.2006—
+1K081777Ventrio Hernia PatchC.R. Bard, Inc.20084
+2K100229Ventrio Hernia PatchC.R. Bard, Inc.2010—
+2K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.2012—
+2K101920Ventrio ST Hernia PatchC.R. Bard, Inc.2011—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201120
201210
201310
201420
201530
201610
201910
202520
FIG. 1 — Lineage of K061314, 2001–2025Source: 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003323Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205
Summary page 2
…teristics, Performance and Intended Use The overall design of the modified XL Composix Kugel is still equivalent to the predicate Composix Kugel describe in K003323. Both the modified XL Composix Kugel and the predicate Composix Kugel described in K003323 consist of two layers of p…
Davol, Inc.20013

Also cleared against K003323: 1 other device →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081777Ventrio Hernia PatchC.R. Bard, Inc.200814

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?

  • Its one ancestor has a recall.
  • Of its descendants, K081777 (C.R. Bard, Inc., 2008) has gone furthest, with 14 descendants of its own.
  • 1 other device also cites its predicate K003323.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use

in the reconstruction of soft tissue deficiencies, such as for the repair of hernias

and chest wall defects.

Indications for use as stated in the FDA summary.

Also cleared against K003323

1 other device cites the same predicate.

  • K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005

More from Davol Inc., Sub. C. R. Bard, Inc.

68 FDA decisions under this applicant name. See the company

  • N17600/S047Avitene Microfibrillar Collagen Hemostat (MCH) Flour; Avitene Microfibrillar Collagen Hemostat (MCH)…Davol Inc., Sub. C. R. Bard, Inc. · 2026
  • N17600/S046Avitene™ Flowable Collagen HemostatDavol Inc., Sub. C. R. Bard, Inc. · 2026
  • N17600/S043Avitene Flowable Collagen HemostatDavol Inc., Sub. C. R. Bard, Inc. · 2025
  • N17600/S044Avitene™ Microfibrillar Collagen HemostatDavol Inc., Sub. C. R. Bard, Inc. · 2025
  • N17600/S042Avitene Microfibrillar Collagen HemostatDavol Inc., Sub. C. R. Bard, Inc. · 2025

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/K061314 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061314: Bard Extra Large Composix Kugel Hernia Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061314

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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