510(k) · Cleared

Cleared

ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH

K143743510(k) TraditionalCleared Sep 18, 2015261-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, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Sep 18, 2015 as substantially equivalent to K110820 (C.R. Bard, Inc., 2011) and 3 other predicates after a 261-day review. Its family tree reaches back 9 generations to 1997. 2 later devices descend from it.

Decided: Sep 18, 2015
Review: 261 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 4

Its longest line of descent runs back 9 generations to K971745 (1997). 38 ancestors in all, the oldest K810428 (1981). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 9 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
5 generations between
3 generations backK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
2 generations backK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
1 generation backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
This deviceK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
Descendant · cites it directly · 1 of its ownK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
Descendant · 2 generations on · 0 of its ownK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018

Show all 9 generations

Root · 9 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
8 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
7 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
6 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
5 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
4 generations backK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
3 generations backK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
2 generations backK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
1 generation backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
This deviceK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard · 2017 · cites it directly1descendant
K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K971745	Bard Composite Prosthesis	Davol Inc., Sub. C. R. Bard, Inc.	1997	—
−8	K994328	Sepramesh Biosurgical Composite, Model SMBC-XXX	Genzyme Corp.	2000	—
−7	K040868	Sepramesh IP Bioresorbable Barrier - Permanent Mesh	Genzyme Corp.	2004	—
−6	K053066	Sepramesh IP Bioresorbable Coating/Permanent Mesh	Genzyme Corporation	2005	—
−5	K063739	Sepramesh, Model 5959-1214	Genzyme Corporation	2007	—
−4	K101851	Ventralight ST Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2010	2
−3	K110820	Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System	C.R. Bard, Inc.	2011	—
−2	K122436	Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…	C.R. Bard, Inc.	2012	15
−1	K130968	Ventralight ST Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2013	4
0 (this device)	K143743	ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH	C.R. Bard, Inc.	2015	—
+1	K170294	VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle…	C. R. Bard	2017	—
+2	K182008	Phasix ST Mesh with Echo 2 Positioning System	C.R. Bard, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1993	1	0
1994	2	0
1995	5	0
1996	1	0
1997	2	0
1998	2	0
2000	1	0
2002	1	0
2004	2	0
2005	1	0
2006	2	0
2007	1	0
2008	2	0
2009	2	0
2010	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	1	0

FIG. 1 — Lineage of K143743, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K110820	Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System Summary page 4 …00, Product Code GCJ III. Predicate Devices • Bard® VENTRALIGHT™ ST Mesh with Echo PS™ Positioning System (Primary Predicate) o K110820 (Davol, Inc.), FDA cleared on 04/01/2011 o K122436 (Davol, Inc.), FDA cleared on 11/02/2012 o K1309…	C.R. Bard, Inc.	2011	—
*	K122436	Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS… Summary page 4 …® VENTRALIGHT™ ST Mesh with Echo PS™ Positioning System (Primary Predicate) o K110820 (Davol, Inc.), FDA cleared on 04/01/2011 o K122436 (Davol, Inc.), FDA cleared on 11/02/2012 o K130968 (Davol, Inc.), FDA cleared on 05/01/2013 • Minnesota M…	C.R. Bard, Inc.	2012	15
*	K130968	Ventralight ST Mesh with Echo PS Positioning System Summary page 4 …(Primary Predicate) o K110820 (Davol, Inc.), FDA cleared on 04/01/2011 o K122436 (Davol, Inc.), FDA cleared on 11/02/2012 o K130968 (Davol, Inc.), FDA cleared on 05/01/2013 • Minnesota Medical Development, Inc. (MMDI) REBOUND HRD V™ Hernia Mesh…	C.R. Bard, Inc.	2013	4
*	K083467	Rebound HRDV Summary page 4 …o K130968 (Davol, Inc.), FDA cleared on 05/01/2013 • Minnesota Medical Development, Inc. (MMDI) REBOUND HRD V™ Hernia Mesh Device o K083467 (MMDI), FDA cleared on 04/23/2009 IV. Reference Device • Genzyme Biosurgery COTTONY II Polyester Nonabsorbable…	Minnesota Medical Development, Inc.	2009	—
†	K021019	Cottony II, Silky II Polydek & Tevdek II Polyester Suture	Genzyme Corp.	2002	7

Also cleared against K110820: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K170294	VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…	C. R. Bard	2017	1

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 18 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
5 of the 38 ancestors have a recall of any class.
Of its descendants, K170294 (C. R. Bard, 2017) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K110820.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	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 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143743 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143743: ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143743

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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