510(k) · Cleared

Cleared

Modification to Brennen Biosynthetic Surgical Mesh Matrix

K030460510(k) SpecialCleared Mar 7, 200323-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

Brennen Medical, Inc. · PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Mar 7, 2003 as substantially equivalent to K982403 (Brennen Medical, Inc., 1998) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.

Decided: Mar 7, 2003
Review: 23 days
Class: Class II
Product code: PAG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K982403 (1998). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK982403 Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 1998
1 generation backK993459 Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 1999
This deviceK030460 Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 2003
Descendant · cites it directly · 6 of its ownK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
Descendant · 2 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
Descendant · 3 generations on · 1 of its ownK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
Descendant · cites it directly · 1 of its ownK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
Descendant · 3 generations on · 0 of its ownK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all

K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · cites it directly6descendants
K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 2 generations on2descendants
K151177XenMatrix AB Surgical GraftC. R. Bard · 2015 · 3 generations on1descendant
K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011 · cites it directly1descendant
K162193XenMatrix AB Surgical GraftC. R. Bard · 2016 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K982403	Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	1998	—
−1	K993459	Modification to Brennen Biosynthetic Surgical Mesh Matrix	Advanced Uroscience, Inc.	1999	—
0 (this device)	K030460	Modification to Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	2003	—
+1	K081272	Porcine Surgical Mesh; Dermal Matrix	Brennen Medical, LLC	2008	4
+2	K133223	Xenmatrix AB Surgical Graft	C.R. Bard, Inc.	2014	—
+3	K151177	XenMatrix AB Surgical Graft	C. R. Bard	2015	—
+1	K111436	Porcine Surgical Mesh, Porcine Dermal Matrix	Brennen Medical, LLC	2011	—
+3	K162193	XenMatrix AB Surgical Graft	C. R. Bard	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2012	1	0
2014	2	0
2015	1	0
2016	1	0

FIG. 1 — Lineage of K030460, 1998–2016Source: 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 PAG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K982403	Brennen Biosynthetic Surgical Mesh Matrix Summary page 1 …Name: (trade name) Classification Name: Surgical Mesh, 21 CFR 878.3300 Common/Usual Name: Surgical Mesh Predicate Device - Brennen Biosynthetic Surgical Mesh Matrix (K982403) and Advanced UroScience Surgical Mesh (K993459). Indication for Use For use in the treatment of hernias where the connective t…	Brennen Medical, Inc.	1998	—
*	K993459	Modification to Brennen Biosynthetic Surgical Mesh Matrix Summary page 1 …l Mesh, 21 CFR 878.3300 Common/Usual Name: Surgical Mesh Predicate Device - Brennen Biosynthetic Surgical Mesh Matrix (K982403) and Advanced UroScience Surgical Mesh (K993459). Indication for Use For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to sup…	Advanced Uroscience, Inc.	1999	—

Also cleared against K982403: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K081272	Porcine Surgical Mesh; Dermal Matrix	Brennen Medical, LLC	2008	6
K111436	Porcine Surgical Mesh, Porcine Dermal Matrix	Brennen Medical, LLC	2011	1

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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K081272 (Brennen Medical, LLC, 2008) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K982403.

How does its category compare?

All PAG devices

PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PAG

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAG

Too few PAG 510(k)s in any year since 2007 to give a median.

Recalls per year · PAG

No recall names PAG since 2007.

Adverse event reports per year · PAG

1in 2023

2007high 299 (2016) · low 0 (2007)2025

MAUDE reports naming product code PAG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	1
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	84
2014	0	—	256
2015	0	—	73
2016	0	—	299
2017	0	—	11
2018	0	—	4
2019	0	—	17
2020	0	—	4
2021	0	—	5
2022	0	—	1
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

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/K030460 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030460: Modification to Brennen Biosynthetic Surgical Mesh Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030460

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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