510(k) · Cleared
ClearedPermacol Surgical Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · FTM Mesh, Surgical
Cleared on May 18, 2012 as substantially equivalent to K043366 (Tissue Science Laboratories, Plc, 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 7 generations to 1988. 4 later devices descend from it.
- Decided
- May 18, 2012
- Review
- 80 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881854 (1988). 29 ancestors in all, the oldest K830889 (1983). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 6 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 5 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 4 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 3 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 2 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 1 generation backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- This deviceK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- Descendant · cites it directly · 1 of its ownK160181 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
- Descendant · cites it directly · 1 of its ownK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK171817 Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK172937 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016 · cites it directly1descendant
- K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · cites it directly1descendant
- K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018 · 2 generations on0descendants
- K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −6 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −5 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −4 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −3 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −2 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −1 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| 0 (this device) | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | — |
| +1 | K160181 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2016 | — |
| +1 | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | 1 |
| +2 | K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018 | — |
| +2 | K172937 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2017 | — |
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 | 3 | 0 |
| 2000 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 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 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043366 | Permacol Surgical ImplantSummary page 1…Permaco TM Surgical Implant COMMON/USUIAL NAME: Surgical Mesh CLASSIFICATION NAME: Surgical Mesh PREDICATE DEVICE(S): Permacol TM Surgical Implant (K043366), Primatrix Ag (K(100261) DEVICE DESCRIPTION: Permaco T MSurgical Implant is a sterile, off-wh… | 2004 |
| * | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldSummary page 1…Surgical Mesh CLASSIFICATION NAME: Surgical Mesh PREDICATE DEVICE(S): Permacol TM Surgical Implant (K043366), Primatrix Ag (K(100261) DEVICE DESCRIPTION: Permaco T MSurgical Implant is a sterile, off-white, moist, tough and fle… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K160181 (Colorado Therapeutics, LLC, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K043366.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Permacolw Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral. scrotal, umbilical, incisional, parastomnal hernias, muscle flap reinforcement and abdominal wall defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120605: Permacol Surgical Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120605
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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