510(k) · Cleared

Cleared

Mesh, Surgical, Polymeric

K982575510(k) TraditionalCleared Nov 6, 1998105-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

United States Surgical, A Division of Tyco Healthc · FTL Mesh, Surgical, Polymeric

Cleared on Nov 6, 1998 as substantially equivalent to K922916 (C.R. Bard, Inc., 1992) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1990.

Decided: Nov 6, 1998
Review: 105 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K905655 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK905655 Nonabsorbable Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco Healthc · 1990
This deviceK982575 Mesh, Surgical, PolymericUnited States Surgical, A Division of Tyco Healthc · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905655	Nonabsorbable Polypropylene Surgical Mesh	United States Surgical, A Division of Tyco Healthc	1990	—
0 (this device)	K982575	Mesh, Surgical, Polymeric	United States Surgical, A Division of Tyco Healthc	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

FIG. 1 — Lineage of K982575, 1990–1998Source: 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
*	K922916	Bard Marlex Mesh Dart Summary page 1 …50 Glover Avenue Norwalk, CT 06856 Jamie Yieh July 23, 1998 Mesh, Surgical, Polymeric Nonabsorbable Surgical Mesh Not yet determined Bard® Marlex® Mesh PerFix™ Plug (K922916) Surgipro* Mesh (K905655) Surgipro* Mesh Plug** device is a nonabsorbable, inert, sterile, porous, surgical mesh knitted from ya…	C.R. Bard, Inc.	1992	—
*	K905655	Nonabsorbable Polypropylene Surgical Mesh Summary page 1 …CT 06856 Jamie Yieh July 23, 1998 Mesh, Surgical, Polymeric Nonabsorbable Surgical Mesh Not yet determined Bard® Marlex® Mesh PerFix™ Plug (K922916) Surgipro* Mesh (K905655) Surgipro* Mesh Plug** device is a nonabsorbable, inert, sterile, porous, surgical mesh knitted from yarns of polypropylene poly…	United States Surgical, A Division of Tyco Healthc	1990	—

Also cleared against K922916: 10 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?

None of the 2 ancestors has a recall.
10 other devices also cite its predicate K922916.

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 Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982575 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982575: Mesh, Surgical, Polymeric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982575

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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