510(k) · Cleared

Cleared

Kensey Nash Macropore Shield

K071695510(k) TraditionalCleared Dec 31, 2007194-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

Kensey Nash Corp. · FTL Mesh, Surgical, Polymeric

Cleared on Dec 31, 2007 as substantially equivalent to K012025 (Macropore Biosurgery, Inc., 2001) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 2001.

Decided: Dec 31, 2007
Review: 194 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K002699 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
1 generation backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
This deviceK071695 Kensey Nash Macropore ShieldKensey Nash Corp. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002699	Parietex Composite (Pco) Mesh	Medical Device Consultants, Inc.	2001	—
−1	K031955	Macropore Surgi-Wrap Mast Bioresorbable Sheet	Macropore Biosurgery, Inc.	2003	—
0 (this device)	K071695	Kensey Nash Macropore Shield	Kensey Nash Corp.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K071695, 2001–2007Source: 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? (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
*	K012025	Macropore Surgiwrap (TS) Summary page 2 …e-amendment devices: MacroPore Surgi-Wrap (TS) and the MacroPore Surgi-Wrap MAST; Class II medical devices that were cleared for marketing in the United States under K012025 and K031955, respectively. Indications For Use The Kensey Nash Bioresorbable Surgical Mesh shares identical indicati…	Macropore Biosurgery, Inc.	2001	—
*	K031955	Macropore Surgi-Wrap Mast Bioresorbable Sheet Summary page 2 …ces: MacroPore Surgi-Wrap (TS) and the MacroPore Surgi-Wrap MAST; Class II medical devices that were cleared for marketing in the United States under K012025 and K031955, respectively. Indications For Use The Kensey Nash Bioresorbable Surgical Mesh shares identical indications for use prin…	Macropore Biosurgery, Inc.	2003	—

Also cleared against K012025: 4 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 6 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.
4 other devices also cite its predicate K012025.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Kensey Nash Bioresorbable Surgical Mesh is to be used wherever temporary wound support

is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other

fascial defects that require the addition of a reinforcing or bridging material to obtain the desired

surgical result. Tissue attachment to the bioresorbable surgical mesh is minimized in case of

direct contact with the viscera.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071695 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071695: Kensey Nash Macropore Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071695

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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