510(k) · Cleared

Cleared

Bard Composite L/P Mesh

K061754510(k) TraditionalCleared Oct 23, 2006124-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 Oct 23, 2006 as substantially equivalent to K052155 (C.R. Bard, Inc., 2005) and 2 other predicates after a 124-day review. Its family tree reaches back 1 generation to 2000. 14 later devices descend from it.

Decided: Oct 23, 2006
Review: 124 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K002684 (2000). 3 ancestors in all. 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK002684 Composix E/X MeshC.R. Bard, Inc. · 2000
This deviceK061754 Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006
Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
Descendant · cites it directly · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
Descendant · 2 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
Descendant · 3 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008high 3 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all

K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · cites it directly6descendants
K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 2 generations on5descendants
K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 2 generations on4descendants
K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002684	Composix E/X Mesh	C.R. Bard, Inc.	2000	—
0 (this device)	K061754	Bard Composite L/P Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2006	—
+1	K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	—
+1	K102766	Composix L/P Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2010	2
+2	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
+3	K130968	Ventralight ST Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2013	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	2	0
2013	1	0
2015	1	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K061754, 2000–2018Source: 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? (3)

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
*	K052155	Bard Large Pore Soft Mesh and Soft Mesh Preshaped Summary page 1 …Classification Name: Surgical Mesh, Polymeric C. Predicate Device Names: Bard Large Pore SoftTm Mesh Pre-Shaped, K052155 (Davol Inc,), FDA cleared on 10/20/2005; Bard Composix® EIX Mesh, K002684 (Dav…	C.R. Bard, Inc.	2005	1
*	K002684	Composix E/X Mesh Summary page 1 …Bard Large Pore SoftTm Mesh Pre-Shaped, K052155 (Davol Inc,), FDA cleared on 10/20/2005; Bard Composix® EIX Mesh, K002684 (Davol Inc.), FDA cleared on 10/1 1/2000; *Davol Delivery System (currently marketed as PrecisionPass Lap…	C.R. Bard, Inc.	2000	—
*	K041641	Davol Delivery System Summary page 1 …FDA cleared on 10/1 1/2000; *Davol Delivery System (currently marketed as PrecisionPass Laparoscopic Delivery Device), K041641 (Davol Inc.), FDA cleared on 07/01/2004. 0. Device Description: The Composix® LIP Mesh, will c…	C.R. Bard, Inc.	2004	—

Also cleared against K052155: 3 other devices →

What descends from it? (14)

See all 14

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	7
K102766	Composix L/P Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2010	6
K082941	Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215	Biomerix Corporation	2009	3
K072974	Surgimesh XB	Aspide Medical	2008	3

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K092726 (Surgical Structures, Ltd., 2010) has gone furthest, with 7 descendants of its own.
3 other devices also cite its predicate K052155.

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

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?

Bard Composix L/P Mesh 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.

https://510kreport.com/device/K061754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061754: Bard Composite L/P Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061754

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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