510(k) Report

510(k) · Cleared

Cleared

Parietex Composite (Pco) Mesh

K002699510(k) TraditionalCleared Feb 15, 2001169-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

Medical Device Consultants, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Feb 15, 2001 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 123 later devices descend from it.

Decided
Feb 15, 2001
Review
169 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

123 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2011: 9 descendants cleared2005: 3 descendants cleared2003: 1 descendant cleared2004: 3 descendants cleared2006: 2 descendants cleared2007: 6 descendants cleared2009: 6 descendants cleared2013: 5 descendants cleared2010: 6 descendants cleared2008: 8 descendants cleared2012: 6 descendants cleared2018: 7 descendants cleared2014: 11 descendants cleared2021: 3 descendants cleared2015: 6 descendants cleared2019: 2 descendants cleared2017: 5 descendants cleared2022: 7 descendants cleared2016: 4 descendants cleared2025: 5 descendants cleared2023: 5 descendants cleared2026: 5 descendants cleared2024: 5 descendants cleared2020: 3 descendants cleared200020052010201520202025
  1. This deviceK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
  2. Descendant · cites it directly · 76 of its ownK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
  3. Descendant · cites it directly · 70 of its ownK033376 Ugytex MeshSofradim Production · 2004
  4. Descendant · cites it directly · 61 of its ownK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
  5. Descendant · 2 generations on · 36 of its ownK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
  6. Descendant · cites it directly · 31 of its ownK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

2003: 12004: 32005: 32006: 22007: 62008: 82009: 62010: 62011: 92012: 62013: 52014: 112015: 62016: 42017: 52018: 72019: 22020: 32021: 32022: 72023: 52024: 52025: 52026: 5
2003high 11 (2014) · low 1 (2003)2026

Most influential descendants

Showing 5 of 123 · See all
  • K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003 · cites it directly76descendants
  • K033376Ugytex MeshSofradim Production · 2004 · cites it directly70descendants
  • K040998Modification to Parietex Composite (Pco) MeshSofradim Production · 2004 · cites it directly61descendants
  • K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005 · 2 generations on36descendants
  • K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005 · cites it directly31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002699Parietex Composite (Pco) MeshMedical Device Consultants, Inc.2001—
+1K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc.2003—
+1K033376Ugytex MeshSofradim Production2004—
+1K040998Modification to Parietex Composite (Pco) MeshSofradim Production2004—
+2K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2005—
+1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
200530
200620
200760
200880
200960
201060
201190
201260
201350
2014110
201560
201640
201750
201870
201920
202030
202130
202270
202350
202450
202550
202650
FIG. 1 — Lineage of K002699, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (123)

See all 123

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

NumberDeviceApplicantDecidedDescendants
K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc.200376
K033376Ugytex MeshSofradim Production200470
K040998Modification to Parietex Composite (Pco) MeshSofradim Production200461
K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production200531
K062915Veritas Collagen MatrixSynovis Surgical Innovations200615
K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production201114
K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112
K110815Parietex Optimized Compostie MeshSofradim Production20115

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, K031955 (Macropore Biosurgery, Inc., 2003) has gone furthest, with 76 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

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—

More from Medical Device Consultants, Inc.

14 FDA decisions under this applicant name. See the company

  • K022895Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 200214 recalls
  • K002116S3 Cardioplegia Control Module Version 2.0Medical Device Consultants, Inc. · 2000
  • K000551Image X-70 Plus Dental X-Ray UnitMedical Device Consultants, Inc. · 2000
  • K974164Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 1997
  • K864282Glucose Testcard Use W/Ilex Prompt Clinical CH AnaMedical Device Consultants, Inc. · 1987

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/K002699 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002699: Parietex Composite (Pco) Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002699

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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