510(k) Report

510(k) · Cleared

Cleared

Pelvimesh / Hermesh 7

K070625510(k) TraditionalCleared Aug 1, 2007148-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

Marketing Solutions, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Aug 1, 2007 as substantially equivalent to K053424 (Caldera Medical, Inc., 2006) and 3 other predicates after a 148-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.

Decided
Aug 1, 2007
Review
148 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K921895 (1992). 40 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 2 other ancestors1998: 8 other ancestors2003: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors1990: 1 other ancestor2001: 2 other ancestors1994: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestor1996: 3 other ancestors1991: 3 other ancestors1985: 1 other ancestor1983: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor2008: 1 descendant clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K020049 · Fortaflex Surgical Mesh · Organogenesis, Inc. · 2002K043259 · Bioblanket Surgical Mesh · Kensey Nash Corp. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 6 other ancestors4 generations back: 6 other ancestors5 generations back: 8 other ancestors6 generations back: 3 other ancestors 1 generation forward: 1 descendant K043259 · Bioblanket Surgical Mesh · Kensey Nash Corp. · 2005K020049 · Fortaflex Surgical Mesh · Organogenesis, Inc. · 2002K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992−50
  1. Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. 2 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  7. 1 generation backK043259 Bioblanket Surgical MeshKensey Nash Corp. · 2005
  8. This deviceK070625 Pelvimesh / Hermesh 7Marketing Solutions, Inc. · 2007
  9. Descendant · cites it directly · 0 of its ownK081327 RelimeshHerniamesh S.R.L. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K081327RelimeshHerniamesh S.R.L. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−6K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−5K980431SurgisisCook Biotech, Inc.1998—
−4K992159Surgisis SlingCook Biotech, Inc.1999—
−3K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
−2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
−1K043259Bioblanket Surgical MeshKensey Nash Corp.2005—
0 (this device)K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.2007—
+1K081327RelimeshHerniamesh S.R.L.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198810
199010
199130
199210
199310
199410
199630
199710
199880
200030
200120
200220
200310
200420
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K070625, 1992–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K053424Popmesh
Summary page 1
…8 e-mail; [email protected] April 16,2012 (Aensed ) Polymeric Surgical Mesh (product code FTL) Class Il device per 21 CFR 87.8.330 Polymeric Surgical Mesh Hermesh 7 K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Sr…
Caldera Medical, Inc.2006—
*K041632Minimesh Polypropylene Mesh
Summary page 1
…012 (Aensed ) Polymeric Surgical Mesh (product code FTL) Class Il device per 21 CFR 87.8.330 Polymeric Surgical Mesh Hermesh 7 K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash) He…
Mpathy Medical Devices, Ltd.20041
*K973955Herniamesh Surgical Meshes
Summary page 1
…code FTL) Class Il device per 21 CFR 87.8.330 Polymeric Surgical Mesh Hermesh 7 K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash) Hermesh 7 prosthesis are non- absorbable monofilam…
Herniamesh1998—
*K043259Bioblanket Surgical Mesh
Summary page 1
…ic Surgical Mesh Hermesh 7 K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash) Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted mon…
Kensey Nash Corp.2005—

Also cleared against K053424: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081327RelimeshHerniamesh S.R.L.20080

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 15 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
  • 3 of the 40 ancestors have a recall of any class.
  • Of its descendants, K081327 (Herniamesh S.R.L., 2008) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K053424.

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

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
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

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

Hermesh 7 monofilament polypropylene mesh may be.used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.

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

Also cleared against K053424

1 other device cites the same predicate.

  • K120327VertessaCaldera Medical, Inc. · 2012

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K070625 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070625: Pelvimesh / Hermesh 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070625

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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