510(k) · Cleared

Cleared

Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004

K042026510(k) TraditionalCleared Sep 10, 200444-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 10, 2004 as substantially equivalent to K001789 (W. L. Gore & Associates, Inc., 2000) after a 44-day review. Its family tree reaches back 1 generation to 2000. 75 later devices descend from it.

Decided: Sep 10, 2004
Review: 44 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001789 (2000). 75 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001789 Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2000
This deviceK042026 Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003…C.R. Bard, Inc. · 2004
Descendant · cites it directly · 74 of its ownK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
Descendant · 2 generations on · 54 of its ownK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
Descendant · 3 generations on · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
Descendant · 4 generations on · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
Descendant · 2 generations on · 14 of its ownK080442 Seriscaffold Surgical MeshSerica Technologies, Inc. · 2008 · Recalled

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2004high 8 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 75 · See all

K043366Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004 · cites it directly74descendants
K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc · 2005 · 2 generations on54descendants
K070560LRTM Surgical MeshLifecell Corp. · 2007 · 3 generations on50descendants
K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · 4 generations on14descendants
K080442Seriscaffold Surgical MeshSerica Technologies, Inc. · 2008 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001789	Seamguard Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2000	—
0 (this device)	K042026	Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004	C.R. Bard, Inc.	2004	—
+1	K043366	Permacol Surgical Implant	Tissue Science Laboratories, Plc	2004	—
+2	K050355	Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece…	Tissue Science Laboratories, Plc	2005	—
+3	K070560	LRTM Surgical Mesh	Lifecell Corp.	2007	2
+4	K082176	LTM-BPS Surgical Mesh	Lifecell Corp.	2008	—
+2	K080442	Seriscaffold Surgical Mesh	Serica Technologies, Inc.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	2	0
2008	5	0
2009	2	0
2010	2	0
2011	5	0
2012	6	0
2013	6	0
2014	6	0
2015	2	0
2016	8	0
2017	6	0
2018	2	0
2019	1	0
2021	1	0
2022	4	0
2023	2	0
2024	3	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K042026, 2000–2026Source: 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? (2)

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
*	K001789	Seamguard Staple Line Reinforcement Material Summary page 2 …osed device is different from the shape of the memory recoil "ring" in the predicate device. The Gore SEAMIGUARD Staple Line Reinforcement Material (K00 1789) indication includes the repair of hernias, including paracolostorny hernias. This indication is the same as…	W. L. Gore & Associates, Inc.	2000	—
*	—	Bard® Composix® Kugel® Mesh Named without a submission number			—

Also cleared against K001789: 3 other devices →

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K043366	Permacol Surgical Implant	Tissue Science Laboratories, Plc	2004	74

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?

Its one ancestor has no recall.
Of its descendants, K043366 (Tissue Science Laboratories, Plc, 2004) has gone furthest, with 74 descendants of its own.
3 other devices also cite its predicate K001789.

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?

The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042026 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042026: Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042026

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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