510(k) Report

510(k) · Cleared

Recalled · 2011

Ventralex ST Hernia Patch

K101928510(k) TraditionalCleared Mar 23, 2011257-day reviewClass II21 CFR 878.3300Recalls 1

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

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

Cleared on Mar 23, 2011 as substantially equivalent to K100229 (C.R. Bard, Inc., 2010) and 6 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it. It has been recalled once.

Decided
Mar 23, 2011
Review
257 days
Class
Class II
Product code
FTL
Recalls
1
Predicates
7

Its longest line of descent runs back 5 generations to K971745 (1997). 19 ancestors in all, the oldest K810428 (1981). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2008: 2 other ancestors2003: 1 other ancestor2002: 2 other ancestors2006: 2 other ancestors2000: 2 other ancestors1983: 1 other ancestor1981: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor2025: 1 descendant clearedK971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 1997K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 2000K040868 · Sepramesh IP Bioresorbable Barrier - Permanent Mesh · Genzyme Corp. · 2004K053066 · Sepramesh IP Bioresorbable Coating/Permanent Mesh · Genzyme Corporation · 2005K063739 · Sepramesh, Model 5959-1214 · Genzyme Corporation · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant K063739 · Sepramesh, Model 5959-1214 · Genzyme Corporation · 2007K053066 · Sepramesh IP Bioresorbable Coating/Permanent Mesh · Genzyme Corporation · 2005K040868 · Sepramesh IP Bioresorbable Barrier - Permanent Mesh · Genzyme Corp. · 2004K994328 · Sepramesh Biosurgical Composite, Model SMBC-XXX · Genzyme Corp. · 2000K971745 · Bard Composite Prosthesis · Davol Inc., Sub. C. R. Bard, Inc. · 1997−50
  1. Root · 5 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
  2. 4 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
  3. 3 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
  4. 2 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
  5. 1 generation backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  6. This deviceK101928 Ventralex ST Hernia PatchC.R. Bard, Inc. · 2011
  7. Descendant · cites it directly · 0 of its ownK243241 Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K971745Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc.1997—
−4K994328Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp.2000—
−3K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp.2004—
−2K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation2005—
−1K063739Sepramesh, Model 5959-1214Genzyme Corporation2007—
0 (this device)K101928Ventralex ST Hernia PatchC.R. Bard, Inc.2011—
+1K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
199910
200020
200110
200220
200310
200620
200820
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K101928, 1997–2025Source: 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? (7)

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
*K100229Ventrio Hernia Patch
Summary page 1
…Mesh, Polymeric C. Predicate Device Name Trade name: Ventrio Hernia Patch (Davol Inc.) K 100229, K08 1777 Trade name: Sepramesh IP Mesh (Davol Inc.)…
C.R. Bard, Inc.2010—
*K081777Ventrio Hernia Patch
Summary page 1
…ymeric C. Predicate Device Name Trade name: Ventrio Hernia Patch (Davol Inc.) K 100229, K08 1777 Trade name: Sepramesh IP Mesh (Davol Inc.) K040868,…
C.R. Bard, Inc.20084
*K040868Sepramesh IP Bioresorbable Barrier - Permanent Mesh
Summary page 1
…K 100229, K08 1777 Trade name: Sepramesh IP Mesh (Davol Inc.) K040868, K053066, K063739 Trade name: Ventralex Hernia Patch (Davol Inc.)…
Genzyme Corp.2004—
*K053066Sepramesh IP Bioresorbable Coating/Permanent Mesh
Summary page 1
…K 100229, K08 1777 Trade name: Sepramesh IP Mesh (Davol Inc.) K040868, K053066, K063739 Trade name: Ventralex Hernia Patch (Davol Inc.)…
Genzyme Corporation2005—
*K063739Sepramesh, Model 5959-1214
Summary page 1
…K 100229, K08 1777 Trade name: Sepramesh IP Mesh (Davol Inc.) K040868, K053066, K063739 Trade name: Ventralex Hernia Patch (Davol Inc.) K02…
Genzyme Corporation2007—
*K021736Bard Ventralex Hernia Patch, Models 0010302, 0010301
Summary page 1
…K040868, K053066, K063739 Trade name: Ventralex Hernia Patch (Davol Inc.) K02 1736, K024008 D. Device Description The proposed device, Ventralex ST Hernia Patch, is a self-expanding bioresorbable coated, p…
C.R. Bard, Inc.20021
*K024008Small Bard Ventralex Patch
Summary page 1
…K040868, K053066, K063739 Trade name: Ventralex Hernia Patch (Davol Inc.) K02 1736, K024008 D. Device Description The proposed device, Ventralex ST Hernia Patch, is a self-expanding bioresorbable coated, partially…
C.R. Bard, Inc.2003—

Also cleared against K100229: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 4, 2011Not classifiedZ-0144-2012Packaging process controlMislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 3 of the 19 ancestors have a recall of any class.
  • Of its descendants, K243241 (Davol, Inc., A Subsidiary of C.R. Bard, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K100229.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Ventralex ST Hernia Patch is indicated for use in the reinforcement of soft tissue,

where weakness exists, in procedures involving soft tissue repair, including repair of

hernias and deficiencies caused by trocars.

Indications for use as stated in the FDA summary.

Also cleared against K100229

5 other devices cite the same predicate.

  • K142706Modified ONFLEX MeshC.R. Bard, Inc. · 2015
  • K142711ONFLEX MeshC.R. Bard, Inc. · 2015
  • K132441Bard Ventralex Hernia PatchC.R. Bard, Inc. · 2013
  • K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
  • K101920Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K101928 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101928: Ventralex ST Hernia Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101928

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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