510(k) Report

510(k) · Cleared

Cleared

VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval

K170294510(k) TraditionalCleared May 1, 201790-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

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

Cleared on May 1, 2017 as substantially equivalent to K143743 (C.R. Bard, Inc., 2015) after a 90-day review. Its family tree reaches back 10 generations to 1997. 1 later device descends from it.

Decided
May 1, 2017
Review
90 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K971745 (1997). 39 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 2009: 2 other ancestors2010: 2 other ancestors2008: 2 other ancestors2007: 1 other ancestor2006: 2 other ancestors1996: 1 other ancestor2005: 1 other ancestor2004: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors1983: 1 other ancestor1981: 1 other ancestor1994: 2 other ancestors1997: 2 other ancestors1995: 5 other ancestors1993: 1 other ancestor2018: 1 descendant clearedReference device: K130968 · Ventralight ST Mesh with Echo PS Positioning System · C.R. Bard, Inc. · 2013 · recalledK971745 · 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 · 2007K101851 · Ventralight ST Mesh · Davol Inc., Sub. C. R. Bard, Inc. · 2010 · recalledK110820 · Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System · C.R. Bard, Inc. · 2011K122436 · Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System · C.R. Bard, Inc. · 2012 · recalledK130968 · Ventralight ST Mesh with Echo PS Positioning System · C.R. Bard, Inc. · 2013 · recalledK143743 · ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH · C.R. Bard, Inc. · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 10 other ancestors6 generations back: 2 other ancestors7 generations back: 9 other ancestors 1 generation forward: 1 descendant K143743 · ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH · C.R. Bard, Inc. · 2015K130968 · Ventralight ST Mesh with Echo PS Positioning System · C.R. Bard, Inc. · 2013 · recalledK122436 · Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System · C.R. Bard, Inc. · 2012 · recalledK110820 · Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System · C.R. Bard, Inc. · 2011K101851 · Ventralight ST Mesh · Davol Inc., Sub. C. R. Bard, Inc. · 2010 · recalledK063739 · 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. · 1997−10−50
  1. Root · 10 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
  2. 6 generations between
  3. 3 generations backK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
  4. 2 generations backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
  5. 1 generation backK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
  6. This deviceK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
  7. Descendant · cites it directly · 0 of its ownK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018
Show all 10 generations
  1. Root · 10 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
  2. 9 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
  3. 8 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
  4. 7 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
  5. 6 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
  6. 5 generations backK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
  7. 4 generations backK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
  8. 3 generations backK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
  9. 2 generations backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
  10. 1 generation backK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
  11. This deviceK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K971745Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc.1997—
−9K994328Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp.2000—
−8K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp.2004—
−7K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation2005—
−6K063739Sepramesh, Model 5959-1214Genzyme Corporation2007—
−5K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc.20102
−4K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.2011—
−3K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…C.R. Bard, Inc.201215
−2K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.20134
−1K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.2015—
0 (this device)K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle…C. R. Bard2017—
+1K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
199310
199420
199550
199610
199720
199820
200010
200210
200420
200510
200620
200710
200820
200920
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K170294, 1997–2018Source: 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
*K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
Summary page 4
…FTL, ORQ, GCJ III. PREDICATE DEVICE The Predicate Device for this submission is the ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh cleared via 510(k) K143743 by Davol Inc. This Predicate has not been subject to a design- related recall. The Reference Device for this submission, t…
C.R. Bard, Inc.2015—
†K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.20134

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180

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 5 companies; a new generation was cleared every 1.6 years on median.
  • 5 of the 39 ancestors have a recall of any class.
  • Of its descendants, K182008 (C.R. Bard, Inc., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?

VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

The ECHO 2™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.

Indications for use as stated in the FDA summary.

More from C. R. Bard

9 FDA decisions under this applicant name. See the company

  • K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term…C. R. Bard · 2020
  • K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018
  • K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017
  • K162193XenMatrix AB Surgical GraftC. R. Bard · 2016
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 2015

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/K170294 · printed Nov 4, 2026

Cite this page

510(k) Report. “K170294: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170294

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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