510(k) · Cleared
Recalled · Class II · 2024Diaphragmatic Hernia Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia
Cleared on Jun 20, 2014 as substantially equivalent to K974540 (Sentron Medical, Inc., 1998) and 3 other predicates after a 268-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 20, 2014
- Review
- 268 days
- Class
- Class II
- Product code
- OWV
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K881854 (1988). 35 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 7 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 6 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 5 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 4 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 3 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 2 generations backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- 1 generation backK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- This deviceK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK171817 Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018
Most influential descendants
Showing 1 of 1 · See all- K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −7 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −6 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −5 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −4 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −3 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −2 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| −1 | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | — |
| 0 (this device) | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | — |
| +1 | K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 OWV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974540 | Sis Hernia Repair DeviceSummary page 1…the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its pre… | 1998 |
| * | K062697 | Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftSummary page 1…ice handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate P… | 2006 |
| * | K022044 | Surgisis Staple Line ReinforcementSummary page 1…nt. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate PermacolTM Surgical Implant (K 120605), manufactur… | 2002 |
| * | K120605 | Permacol Surgical ImplantSummary page 1…4540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate PermacolTM Surgical Implant (K 120605), manufactured by Covidien. The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technol… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171817 | Biodesign Diaphragmatic Hernia Graft | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2024 | Class II | Z-0833-2025 | Under Investigation by firm | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 35 ancestors have a recall of any class.
- Of its descendants, K171817 (Cook Biotech Incorporated, 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K974540.
How does its category compare?
All OWV devicesOWV Mesh, Surgical, Collagen, Diaphragmatic Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OWV
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · OWV
Too few OWV 510(k)s in any year since 2007 to give a median.
Recalls per year · OWV
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWV
2in 2022
MAUDE reports naming product code OWV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133011: Diaphragmatic Hernia Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133011
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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