510(k) Report

510(k) · Cleared

Cleared

Peri-Strips

K940205510(k) TraditionalCleared May 2, 1994108-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. · FTM Mesh, Surgical

Cleared on May 2, 1994 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 151 later devices descend from it.

Decided
May 2, 1994
Review
108 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
0

151 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2002: 2 descendants cleared1997: 1 descendant cleared2003: 3 descendants cleared2000: 1 descendant cleared1999: 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 deviceK940205 Peri-StripsBio-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 151 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 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 (2001)2026

Most influential descendants

Showing 5 of 151 · 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)K940205Peri-StripsBio-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
199810
199910
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 K940205, 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 FTM? 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 FTM device

  1. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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? (151)

See all 151

3 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
K981756Shelhigh NO-React PneumopledgetsShelhigh, Inc.19981

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 FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—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

Recent decisions in FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
  • K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K940205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940205: Peri-Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940205

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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