510(k) Report

510(k) · Cleared

Cleared

Sis Hernia Graft

K133306510(k) TraditionalCleared Jul 23, 2014268-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

Cook Biotech, Inc. · FTM Mesh, Surgical

Cleared on Jul 23, 2014 as substantially equivalent to K974540 (Sentron Medical, Inc., 1998) and 1 other predicate after a 268-day review. Its family tree reaches back 1 generation to 1998.

Decided
Jul 23, 2014
Review
268 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K974540 (1998). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK974540 · Sis Hernia Repair Device · Sentron Medical, Inc. · 199819952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K974540 · Sis Hernia Repair Device · Sentron Medical, Inc. · 19980
  1. Root · 1 generation backK974540 Sis Hernia Repair DeviceSentron Medical, Inc. · 1998
  2. This deviceK133306 Sis Hernia GraftCook Biotech, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974540Sis Hernia Repair DeviceSentron Medical, Inc.1998—
0 (this device)K133306Sis Hernia GraftCook Biotech, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K133306, 1998–2014Source: 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), the FDA summary (predicates and indications), 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
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K974540Sis Hernia Repair Device
Summary page 1
…ture to improve the device handling characteristics at time of implant. The 515 Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in i…
Sentron Medical, Inc.1998—
*K062697Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft
Summary page 1
…improve the device handling characteristics at time of implant. The 515 Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in its techn…
Cook Biotech, Inc.2006—

Also cleared against K974540: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 5 other devices also cite its predicate K974540.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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—

What is it indicated for?

The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

Indications for use as stated in the FDA summary.

Also cleared against K974540

5 other devices cite the same predicate.

  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall
  • K111695Hybrid GraftCook Biotech, Inc. · 2012
  • K020654Stratasis Sling KitCook Biotech, Inc. · 2002
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  • K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998

More from Cook Biotech, Inc.

31 FDA decisions under this applicant name. See the company

  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall
  • K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013
  • K111695Hybrid GraftCook Biotech, Inc. · 2012
  • K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011
  • K090688Cook Urological GraftCook Biotech, Inc. · 2009

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/K133306 · printed Nov 3, 2026

Cite this page

510(k) Report. “K133306: Sis Hernia Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133306

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026