510(k) · Cleared
ClearedPermacol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Science Laboratories, Plc · FTL Mesh, Surgical, Polymeric
Cleared on Feb 17, 2000 after a 202-day review. The FDA summary names its predicate without a number. 170 later devices descend from it.
- Decided
- Feb 17, 2000
- Review
- 202 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
170 later devices descend from it, 8 citing it directly.
- This deviceK992556 PermacolTissue Science Laboratories, Plc · 2000
- Descendant · cites it directly · 95 of its ownK013625 PermacolTissue Science Laboratories, Plc · 2002
- Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- Descendant · cites it directly · 74 of its ownK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- Descendant · cites it directly · 56 of its ownK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- Descendant · cites it directly · 54 of its ownK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
Showing 5 of 170 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 170 · See all- K013625PermacolTissue Science Laboratories, Plc · 2002 · cites it directly95descendants
- K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants
- K043366Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004 · cites it directly74descendants
- K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002 · cites it directly56descendants
- K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc · 2005 · cites it directly54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992556 | Permacol | Tissue Science Laboratories, Plc | 2000 | — |
| +1 | K013625 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
| +2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| +1 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| +1 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| +1 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 11 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 14 | 0 |
| 2017 | 12 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 11 | 0 |
| 2026 | 4 | 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 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 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | — | Polymeric Surgical Mesh Named without a submission number | |
| * | — | GraftPatch® Named without a submission number | |
| * | — | Rapi-Seal™ Patch Named without a submission number | |
| * | — | Biosynthetic Surgical Mesh Named without a submission number | |
| * | — | Peri-Guard® family of products Named without a submission number | |
| * | — | Glycar Tissue Repair Patch Named without a submission number |
What descends from it? (170)
See all 1708 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013625 | Permacol | 2002 | 95 |
| K043366 | Permacol Surgical Implant | 2004 | 74 |
| K020455 | Tissuemend Soft Tissue Repair Matrix | 2002 | 56 |
| K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models… | 2005 | 54 |
| K021160 | Dermmatrix Surgical Mesh | 2002 | 38 |
| K140495 | Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode | 2014 | 6 |
| K061445 | Surgimesh WN | 2007 | 5 |
| K082079 | Regen Collagen Scaffold (CS) | 2008 | 2 |
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, K013625 (Tissue Science Laboratories, Plc, 2002) has gone furthest, with 95 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Permacol™ is intended for use as a soft tissue patch 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 and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992556 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992556: Permacol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992556
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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