510(k) Report

510(k) · Cleared

Cleared

Bard Marlex Mesh Dart

K922916510(k) TraditionalCleared Aug 24, 199268-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

C.R. Bard, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Aug 24, 1992 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 133 later devices descend from it.

Decided
Aug 24, 1992
Review
68 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

133 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2014: 7 descendants cleared2007: 3 descendants cleared2010: 6 descendants cleared2012: 16 descendants cleared1998: 1 descendant cleared2005: 3 descendants cleared2008: 14 descendants cleared2000: 1 descendant cleared2001: 1 descendant cleared2004: 4 descendants cleared2013: 10 descendants cleared2011: 8 descendants cleared2009: 9 descendants cleared2003: 1 descendant cleared2006: 5 descendants cleared2016: 4 descendants cleared2022: 4 descendants cleared2015: 6 descendants cleared2018: 7 descendants cleared2024: 4 descendants cleared2025: 4 descendants cleared2017: 2 descendants cleared2026: 5 descendants cleared2020: 3 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK922916 Bard Marlex Mesh DartC.R. Bard, Inc. · 1992
  2. Descendant · cites it directly · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  3. Descendant · 2 generations on · 80 of its ownK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  4. Descendant · 3 generations on · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  5. Descendant · 4 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  6. Descendant · 4 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

1998: 12000: 12001: 12003: 12004: 42005: 32006: 52007: 32008: 142009: 92010: 62011: 82012: 162013: 102014: 72015: 62016: 42017: 22018: 72019: 12020: 32021: 12022: 42023: 32024: 42025: 42026: 5
1998high 16 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 133 · See all
  • K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · cites it directly113descendants
  • K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001 · 2 generations on80descendants
  • K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · 3 generations on79descendants
  • K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 4 generations on74descendants
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 4 generations on70descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922916Bard Marlex Mesh DartC.R. Bard, Inc.1992—
+1K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
+2K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
+3K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
+4K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
+4K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200310
200440
200530
200650
200730
2008140
200990
201060
201180
2012160
2013100
201470
201560
201640
201720
201870
201910
202030
202110
202240
202330
202440
202540
202650
FIG. 1 — Lineage of K922916, 1992–2026Source: 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), 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? (133)

See all 133

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

NumberDeviceApplicantDecidedDescendants
K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000113
K101519Parietex Plug and PatchSofradim Production20106
K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083
K113552Freedom Inguinal Hernia ImplantInsightra Medical20121
K070224Ultrapro PlugETHICON, Inc.20071
K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical20140
K133198Ultrapro Comfort PlugETHICON, Inc.20140
K120844Medlinx Surgical MeshMedlinx Acala Pte, Ltd.20120
K0709184DDOMECousin Biotech20070
K050969Inclose Surgical Mesh SystemAnulex Technologies, Inc.20050

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, K002721 (American Medical Systems, Inc., 2000) has gone furthest, with 113 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 C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

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  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K922916 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922916: Bard Marlex Mesh Dart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922916

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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