510(k) Report

510(k) · Cleared

Cleared

Glycar Staple Strips

K954665510(k) TraditionalCleared Feb 14, 1996127-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

Glycar, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Feb 14, 1996 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 205 later devices descend from it.

Decided
Feb 14, 1996
Review
127 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

205 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2005: 6 descendants cleared2000: 1 descendant cleared2002: 6 descendants cleared2004: 3 descendants cleared2009: 14 descendants cleared2016: 10 descendants cleared2008: 13 descendants cleared2006: 9 descendants cleared2010: 9 descendants cleared2013: 7 descendants cleared2003: 3 descendants cleared2015: 6 descendants cleared2019: 6 descendants cleared2017: 13 descendants cleared2011: 10 descendants cleared2007: 9 descendants cleared2018: 8 descendants cleared2012: 9 descendants cleared2014: 6 descendants cleared2025: 13 descendants cleared2024: 12 descendants cleared2021: 6 descendants cleared2023: 6 descendants cleared2026: 10 descendants cleared2022: 7 descendants cleared2020: 2 descendants cleared1995200020052010201520202025
  1. This deviceK954665 Glycar Staple StripsGlycar, Inc. · 1996
  2. Descendant · cites it directly · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
  3. Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  4. Descendant · 3 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  5. Descendant · 3 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  6. Descendant · 4 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004

Showing 5 of 205 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12002: 62003: 32004: 32005: 62006: 92007: 92008: 132009: 142010: 92011: 102012: 92013: 72014: 62015: 62016: 102017: 132018: 82019: 62020: 22021: 62022: 72023: 62024: 122025: 132026: 10
1999high 14 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 205 · See all
  • K992159Surgisis SlingCook Biotech, Inc. · 1999 · cites it directly204descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 3 generations on102descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 3 generations on91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 4 generations on72descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954665Glycar Staple StripsGlycar, Inc.1996—
+1K992159Surgisis SlingCook Biotech, Inc.1999—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+3K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+4K042809CuffpatchOrganogenesis, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200260
200330
200430
200560
200690
200790
2008130
2009140
201090
2011100
201290
201370
201460
201560
2016100
2017130
201880
201960
202020
202160
202270
202360
2024120
2025130
2026100
FIG. 1 — Lineage of K954665, 1996–2026Source: 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? (205)

See all 205

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

NumberDeviceApplicantDecidedDescendants
K992159Surgisis SlingCook Biotech, Inc.1999204

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, K992159 (Cook Biotech, Inc., 1999) has gone furthest, with 204 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 Glycar, Inc.

5 FDA decisions under this applicant name. See the company

  • K963368Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name…Glycar, Inc. · 1997
  • K963967Glycar Pericardial PatchGlycar, Inc. · 19972 Class I recalls
  • K963175Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingGlycar, Inc. · 1996
  • K942911Glycar Tissue Repair PatchGlycar, Inc. · 1994

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/K954665 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954665: Glycar Staple Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954665

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