510(k) Report

510(k) · Cleared

Cleared

Peri-Strips Planar Configuration Staple Line Reinforcement

K942583510(k) TraditionalCleared Jul 8, 199437-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

Bio-Vascular, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jul 8, 1994 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it.

Decided
Jul 8, 1994
Review
37 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

149 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared1997: 1 descendant cleared2003: 3 descendants cleared2000: 1 descendant cleared2004: 2 descendants cleared2007: 5 descendants cleared2005: 3 descendants cleared2019: 6 descendants cleared2017: 15 descendants cleared2015: 7 descendants cleared2009: 1 descendant cleared2018: 10 descendants cleared2013: 10 descendants cleared2008: 4 descendants cleared2010: 2 descendants cleared2006: 1 descendant cleared2012: 7 descendants cleared2011: 1 descendant cleared2014: 10 descendants cleared2022: 10 descendants cleared2024: 3 descendants cleared2023: 9 descendants cleared2016: 10 descendants cleared2020: 7 descendants cleared2026: 9 descendants cleared2021: 6 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK942583 Peri-Strips Planar Configuration Staple Line ReinforcementBio-Vascular, Inc. · 1994
  2. Descendant · cites it directly · 148 of its ownK971048 Peri-Strips Dry - Staple Line ReinforcementBio-Vascular, Inc. · 1997
  3. Descendant · 2 generations on · 147 of its ownK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
  4. Descendant · cites it directly · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
  5. Descendant · 2 generations on · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  6. Descendant · 3 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

1997: 12000: 12002: 22003: 32004: 22005: 32006: 12007: 52008: 42009: 12010: 22011: 12012: 72013: 102014: 102015: 72016: 102017: 152018: 102019: 62020: 72021: 62022: 102023: 92024: 32025: 42026: 9
1997high 15 (2017) · low 0 (1998)2026

Most influential descendants

Showing 5 of 149 · See all
  • K971048Peri-Strips Dry - Staple Line ReinforcementBio-Vascular, Inc. · 1997 · cites it directly148descendants
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc. · 2000 · 2 generations on147descendants
  • K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · cites it directly145descendants
  • K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on143descendants
  • K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 3 generations on102descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942583Peri-Strips Planar Configuration Staple Line ReinforcementBio-Vascular, Inc.1994—
+1K971048Peri-Strips Dry - Staple Line ReinforcementBio-Vascular, Inc.1997—
+2K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated…Bio-Vascular, Inc.2000—
+1K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002—
+2K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
+3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200220
200330
200420
200530
200610
200750
200840
200910
201020
201110
201270
2013100
2014100
201570
2016100
2017150
2018100
201960
202070
202160
2022100
202390
202430
202540
202690
FIG. 1 — Lineage of K942583, 1994–2026Source: 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? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K971048Peri-Strips Dry - Staple Line ReinforcementBio-Vascular, Inc.1997148
K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145

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, K971048 (Bio-Vascular, Inc., 1997) has gone furthest, with 148 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 Bio-Vascular, Inc.

26 FDA decisions under this applicant name. See the company

  • K002233Bvi SlingBio-Vascular, Inc. · 20001 recall
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-TreatedBio-Vascular, Inc. · 2000
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls

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The FTL category page

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  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
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https://510kreport.com/device/K942583 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942583: Peri-Strips Planar Configuration Staple Line Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942583

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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