510(k) · Cleared

Cleared

Atrium Lite Mesh

K002093510(k) SpecialCleared Jul 24, 200013-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

Atrium Medical Corp. · FTL Mesh, Surgical, Polymeric

Cleared on Jul 24, 2000 after a 13-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 33 later devices descend from it.

Decided: Jul 24, 2000
Review: 13 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 0

33 later devices descend from it, 4 citing it directly.

This deviceK002093 Atrium Lite MeshAtrium Medical Corp. · 2000
Descendant · cites it directly · 26 of its ownK043081 Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc. · 2004
Descendant · 2 generations on · 25 of its ownK052864 Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005
Descendant · 3 generations on · 24 of its ownK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
Descendant · 4 generations on · 17 of its ownK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
Descendant · 5 generations on · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2004high 5 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 33 · See all

K043081Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc. · 2004 · cites it directly26descendants
K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005 · 2 generations on25descendants
K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006 · 3 generations on24descendants
K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · 4 generations on17descendants
K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002093	Atrium Lite Mesh	Atrium Medical Corp.	2000	—
+1	K043081	Gore Polypropylene Hernia Mesh	W. L. Gore & Associates, Inc.	2004	—
+2	K052864	Tyrx Surgical Mesh, Model SMPC-0501	Tyrx Pharma, Inc.	2005	—
+3	K053656	Tyrx Antimicrobial Mesh	Tyrx Pharma, Inc.	2006	—
+4	K063091	Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601	Tyrx Pharma, Inc.	2008	3
+5	K130943	Aigis RX R PM/ Aigis RX R Icd	Tyrx, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2008	2	0
2010	1	0
2012	1	0
2013	4	0
2014	3	0
2015	5	0
2016	2	0
2017	1	0
2018	4	0
2019	1	0
2020	3	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K002093, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K043081	Gore Polypropylene Hernia Mesh	W. L. Gore & Associates, Inc.	2004	26
K073579	Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN	Feg Textiltechnik Forschungs-Und Entwicklungsgesel	2008	3
K151437	ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug	Atrium Medical Corporation	2015	0
K142192	Insightra Freedom Ventral Hernia Repair System	Insightra Medical	2015	0

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?

Of its descendants, K043081 (W. L. Gore & Associates, Inc., 2004) has gone furthest, with 26 descendants of its own.

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	—

https://510kreport.com/device/K002093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002093: Atrium Lite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002093

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026