510(k) · Cleared

Recalled · 2010

Bard Large Pore Soft Mesh and Soft Mesh Preshaped

K052155510(k) TraditionalCleared Oct 20, 200573-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 Oct 20, 2005 after a 73-day review. The FDA summary names its predicate without a number. 21 later devices descend from it. It has been recalled once.

Decided: Oct 20, 2005
Review: 73 days
Class: Class II
Product code: FTL
Recalls: 1
Predicates: 0

21 later devices descend from it, 4 citing it directly.

This deviceK052155 Bard Large Pore Soft Mesh and Soft Mesh PreshapedC.R. Bard, Inc. · 2005
Descendant · cites it directly · 14 of its ownK061754 Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006
Descendant · 2 generations on · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006high 3 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 21 · See all

K061754Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006 · cites it directly14descendants
K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · 2 generations on7descendants
K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052155	Bard Large Pore Soft Mesh and Soft Mesh Preshaped	C.R. Bard, Inc.	2005	—
+1	K061754	Bard Composite L/P Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2006	—
+2	K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	—
+2	K102766	Composix L/P Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2010	2
+3	K110820	Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System	C.R. Bard, Inc.	2011	—
+3	K122436	Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…	C.R. Bard, Inc.	2012	15

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	3	0
2013	1	0
2015	1	0
2017	1	0
2018	1	0
2020	1	0
2022	1	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K052155, 2005–2025Source: 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

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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	Recalls
*	—	Bard Mesh (Davol Inc.) Named without a submission number	—
*	—	Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.) Named without a submission number	—
*	—	Ethicon Prolene Soft Polypropylene Mesh (Ethicon, Inc.) Named without a submission number	—

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K061754	Bard Composite L/P Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2006	14
K193144	T-Line Hernia Mesh	Deep Blue Medical Advances, Inc.	2020	3
K250098	Bard Soft Mesh; Bard Soft Mesh Pre-Shaped	Davol, Inc.	2025	0
K113311	TIO2MESH TM	Biocer Entwicklungs GmbH	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2010	Not classified	Z-0446-2011	Process control	Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K061754 (Davol Inc., Sub. C. R. Bard, Inc., 2006) has gone furthest, with 14 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.

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® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052155 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052155: Bard Large Pore Soft Mesh and Soft Mesh Preshaped.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052155

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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