510(k) · Cleared

Cleared

Popmesh

K053424510(k) TraditionalCleared Feb 22, 200676-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

Caldera Medical, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Feb 22, 2006 as substantially equivalent to K001122 (ETHICON, Inc., 2000) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.

Decided: Feb 22, 2006
Review: 76 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K001122 (2000). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001122 Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc. · 2000
This deviceK053424 PopmeshCaldera Medical, Inc. · 2006
Descendant · cites it directly · 5 of its ownK120327 VertessaCaldera Medical, Inc. · 2012
Descendant · 2 generations on · 1 of its ownK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
Descendant · 2 generations on · 1 of its ownK122440 Restorelle LColoplast Corp. · 2012 · Recalled
Descendant · cites it directly · 1 of its ownK070625 Pelvimesh / Hermesh 7Marketing Solutions, Inc. · 2007
Descendant · 3 generations on · 0 of its ownK150016 Vertessa LiteCaldera Medical, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 3 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all

K120327VertessaCaldera Medical, Inc. · 2012 · cites it directly5descendants
K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013 · 2 generations on1descendant
K122440Restorelle LColoplast Corp. · 2012 · 2 generations on1descendant
K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc. · 2007 · cites it directly1descendant
K150016Vertessa LiteCaldera Medical, Inc. · 2015 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001122	Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh	ETHICON, Inc.	2000	—
0 (this device)	K053424	Popmesh	Caldera Medical, Inc.	2006	—
+1	K120327	Vertessa	Caldera Medical, Inc.	2012	—
+2	K123337	Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM	Caldera Medical	2013	—
+2	K122440	Restorelle L	Coloplast Corp.	2012	1
+1	K070625	Pelvimesh / Hermesh 7	Marketing Solutions, Inc.	2007	—
+3	K150016	Vertessa Lite	Caldera Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2012	3	0
2013	2	0
2015	1	0

FIG. 1 — Lineage of K053424, 2000–2015Source: 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K041362	FDA’s K041362 is Resmed Hospital Full Face Mask Our OCR of the scanned summary read K041362, FDA’s number for Resmed Hospital Full Face Mask (Resmed, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mumesh® Polypropylene Mesh”. Kept off the family tree. Summary page 1 …Polymeric Surgical Mesh (Product Code FTL) 1s a Class device per 21 CFR 878.3300 COMMON NAME:: Polymeric Surgical Mesh PROPRIETARY NAME: POPmegh ™ PREDICATE DEVICES: K041362 Muumeshi® Polyproviene Mesh (Mpathy Medical Devices Linted) K0O1122 Prolenc® (Ethicon \| Inc)) K002672 Vypro® 11 (Eithicon. Inc.)…	Resmed, Ltd.	2004	—
*	K001122	Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh	ETHICON, Inc.	2000	—
*	K002672	Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh Summary page 1 …ric Surgical Mesh PROPRIETARY NAME: POPmegh ™ PREDICATE DEVICES: K041362 Muumeshi® Polyproviene Mesh (Mpathy Medical Devices Linted) K0O1122 Prolenc® (Ethicon \| Inc)) K002672 Vypro® 11 (Eithicon. Inc.) DEVICE DESCRIPTION: POPmesh™ 1s a non-absorbable polypropylene mesh constructed from knitted monoefi…	ETHICON, Inc.	2000	—

Also cleared against K001122: 12 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K120327	Vertessa	Caldera Medical, Inc.	2012	5
K070625	Pelvimesh / Hermesh 7	Marketing Solutions, Inc.	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K120327 (Caldera Medical, Inc., 2012) has gone furthest, with 5 descendants of its own.
12 other devices also cite its predicate K001122.

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?

POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

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/K053424 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053424: Popmesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053424

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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