510(k) Report

510(k) · Cleared

Cleared

Parietex Plug and Patch

K101519510(k) TraditionalCleared Nov 5, 2010156-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

Sofradim Production · FTL Mesh, Surgical, Polymeric

Cleared on Nov 5, 2010 as substantially equivalent to K922916 (C.R. Bard, Inc., 1992) and 3 other predicates after a 156-day review. Its family tree reaches back 5 generations to 1999. 6 later devices descend from it.

Decided
Nov 5, 2010
Review
156 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K991400 (1999). 14 ancestors in all, the oldest K810428 (1981). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor1992: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1993: 1 other ancestor1981: 1 other ancestor2002: 1 other ancestor2014: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK991400 · Parietene Polypropylene Mesh · Sofradim Production · 1999×2: 2 generations cleared close together, K033376 (2004), K040998 (2004) ×2: 2 generations cleared close together, K073287 (2008), K081050 (2008) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K081050 · Parietex Progrip Mesh · Sofradim Production · 2008K073287 · Prevadh Mesh · Sofradim Production · 2008K040998 · Modification to Parietex Composite (Pco) Mesh · Sofradim Production · 2004K033376 · Ugytex Mesh · Sofradim Production · 2004K991400 · Parietene Polypropylene Mesh · Sofradim Production · 1999−50+5
  1. Root · 5 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
  2. 4 generations backK033376 Ugytex MeshSofradim Production · 2004
  3. 3 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
  4. 2 generations backK073287 Prevadh MeshSofradim Production · 2008
  5. 1 generation backK081050 Parietex Progrip MeshSofradim Production · 2008
  6. This deviceK101519 Parietex Plug and PatchSofradim Production · 2010
  7. Descendant · cites it directly · 5 of its ownK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014
  8. Descendant · 2 generations on · 3 of its ownK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
  9. Descendant · 3 generations on · 2 of its ownK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
  10. Descendant · 4 generations on · 1 of its ownK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
  11. Descendant · 5 generations on · 0 of its ownK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12022: 12024: 12025: 12026: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production · 2014 · cites it directly5descendants
  • K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production · 2022 · 2 generations on3descendants
  • K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024 · 3 generations on2descendants
  • K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025 · 4 generations on1descendant
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K991400Parietene Polypropylene MeshSofradim Production1999—
−4K033376Ugytex MeshSofradim Production2004—
−3K040998Modification to Parietex Composite (Pco) MeshSofradim Production2004—
−2K073287Prevadh MeshSofradim Production2008—
−1K081050Parietex Progrip MeshSofradim Production2008—
0 (this device)K101519Parietex Plug and PatchSofradim Production2010—
+1K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)…Sofradim Production2014—
+2K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex…Sofradim Production2022—
+3K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production2024—
+4K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production2025—
+5K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020…Sofradim Production2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
199210
199310
199910
200120
200210
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
202210
202410
202510
202610
FIG. 1 — Lineage of K101519, 1999–2026Source: 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
*K922916Bard Marlex Mesh Dart
Summary page 1
…lug and Patch COMMON/USUAL NAME: Surgical Mesh CLASSIFICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): BARD" MESH PERFIX6 PLUG (K922916) PARIETEX PROGRI PTM Mesh (K081 050) PARIETEX Tm Lightweight Monofila…
C.R. Bard, Inc.1992—
*K081050Parietex Progrip Mesh
Summary page 1
…FICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): BARD" MESH PERFIX6 PLUG (K922916) PARIETEX PROGRI PTM Mesh (K081 050) PARIETEX Tm Lightweight Monofilament Polyester Mesh (K090858) PARIET…
Sofradim Production2008—
*K090858Parietex Monofilament Polyester Mesh
Summary page 1
…RFIX6 PLUG (K922916) PARIETEX PROGRI PTM Mesh (K081 050) PARIETEX Tm Lightweight Monofilament Polyester Mesh (K090858) PARIETEX' TM PARASTOMAL MESH (K081126) DEVICE DESCRIPTION: PARIETEX TM Plug and Patch is…
Sofradim Production2009—
*K081126Parietex Composite Mono PM Mesh
Summary page 1
…M Mesh (K081 050) PARIETEX Tm Lightweight Monofilament Polyester Mesh (K090858) PARIETEX' TM PARASTOMAL MESH (K081126) DEVICE DESCRIPTION: PARIETEX TM Plug and Patch is a kit composed of: * A pre-cut non a…
Sofradim Production20081

Also cleared against K922916: 10 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145

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 11 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • Of its descendants, K142900 (Sofradim Production, 2014) has gone furthest, with 5 descendants of its own.
  • 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. 2010, 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?

PARIETEX Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.

Indications for use as stated in the FDA summary.

Also cleared against K922916

10 other devices cite the same predicate.

  • K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical · 2014
  • K133198Ultrapro Comfort PlugETHICON, Inc. · 2014
  • K120844Medlinx Surgical MeshMedlinx Acala Pte, Ltd. · 2012
  • K113552Freedom Inguinal Hernia ImplantInsightra Medical · 2012
  • K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel · 2008
  • K0709184DDOMECousin Biotech · 2007

More from Sofradim Production

43 FDA decisions under this applicant name. See the company

  • K262443Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)Sofradim Production · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production · 2025
  • K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
  • K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024

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/K101519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101519: Parietex Plug and Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101519

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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