510(k) · Cleared

Cleared

Modified ONFLEX Mesh

K142706510(k) TraditionalCleared Mar 25, 2015184-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 Mar 25, 2015 as substantially equivalent to K091659 (C.R. Bard, Inc., 2009) and 3 other predicates after a 184-day review. Its family tree reaches back 4 generations to 2001.

Decided: Mar 25, 2015
Review: 184 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K003323 (2001). 11 ancestors in all, the oldest K963141 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001 · Recalled
3 generations backK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
2 generations backK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled
1 generation backK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
This deviceK142706 Modified ONFLEX MeshC.R. Bard, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003323	Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205	Davol, Inc.	2001	3
−3	K061314	Bard Extra Large Composix Kugel Hernia Patch	Davol Inc., Sub. C. R. Bard, Inc.	2006	—
−2	K081777	Ventrio Hernia Patch	C.R. Bard, Inc.	2008	4
−1	K100229	Ventrio Hernia Patch	C.R. Bard, Inc.	2010	—
0 (this device)	K142706	Modified ONFLEX Mesh	C.R. Bard, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0
2000	1	0
2002	1	0
2006	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K142706, 2001–2015Source: 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? (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
*	K091659	Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 Summary page 4 …Class: - Class II Product Code: - FTL III. Predicate Devices  Bard® 3DMax™ Light Mesh o K091659 (Davol, Inc.), FDA cleared on 08/08/2009  Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA clear…	C.R. Bard, Inc.	2009	—
*	K081777	Ventrio Hernia Patch Summary page 4 …cate Devices  Bard® 3DMax™ Light Mesh o K091659 (Davol, Inc.), FDA cleared on 08/08/2009  Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA cleared on 09/29/2008 o K100229 (Davol, Inc.), FDA cleared on 04/21/2010  Bard® Modifi…	C.R. Bard, Inc.	2008	4
*	K100229	Ventrio Hernia Patch Summary page 4 …K091659 (Davol, Inc.), FDA cleared on 08/08/2009  Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA cleared on 09/29/2008 o K100229 (Davol, Inc.), FDA cleared on 04/21/2010  Bard® Modified Kugel™ Hernia Patch o K963141 (Davol, Inc.), FDA…	C.R. Bard, Inc.	2010	—
*	K963141	Kugel Hernia Patch Summary page 4 …7 (Davol, Inc.), FDA cleared on 09/29/2008 o K100229 (Davol, Inc.), FDA cleared on 04/21/2010  Bard® Modified Kugel™ Hernia Patch o K963141 (Davol, Inc.), FDA cleared on 10/11/1996 No reference devices were used in this submission. IV. Device Description The p…	Douglas Bueschel	1996	—

Also cleared against K091659: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
2 of the 11 ancestors have a recall of any class.
3 other devices also cite its predicate K091659.

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?

The Modified ONFLEX Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142706: Modified ONFLEX Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142706

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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