510(k) · Cleared
ClearedPermacol Surgical Implant
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 Dec 17, 2004 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 3 other predicates after a 9-day review. Its family tree reaches back 3 generations to 1992. 74 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K921895 (1992). 12 ancestors in all, the oldest K830889 (1983). 74 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- Descendant · cites it directly · 54 of its ownK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- Descendant · 2 generations on · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- Descendant · 3 generations on · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · cites it directly · 14 of its ownK080442 Seriscaffold Surgical MeshSerica Technologies, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc · 2005 · cites it directly54descendants
- K070560LRTM Surgical MeshLifecell Corp. · 2007 · 2 generations on50descendants
- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · 3 generations on14descendants
- K080442Seriscaffold Surgical MeshSerica Technologies, Inc. · 2008 · cites it directly14descendants
- K142326HP Tissue MatrixLifecell Corporation · 2014 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| +1 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| +2 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| +3 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +1 | K080442 | Seriscaffold Surgical Mesh | Serica Technologies, Inc. | 2008 | 1 |
| +4 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 8 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 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? (5)
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 |
|---|---|---|---|
| * | K992556 | PermacolSummary page 1…or Usual Name Surgical Mesh Classification Name Surgical Mesh Predicate Devices Surgical Mesh (K992556), Bio- Permacol® Crosslinked Porcine Dermal Collagen 3 162), Cook Biotech's Vascular Inc's Supple Peni-… | 2000 |
| * | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Summary page 1…Surgical Mesh (K992556), Bio- Permacol® Crosslinked Porcine Dermal Collagen 3 162), Cook Biotech's Vascular Inc's Supple Peni-Guard® (K983 162), Peri-Guard®(K98(K042026). Hernia Patch SurgiSISTM (K98043 I) and Bard… | 1998 |
| * | K042026 | Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004Summary page 1…92556), Bio- Permacol® Crosslinked Porcine Dermal Collagen 3 162), Cook Biotech's Vascular Inc's Supple Peni-Guard® (K983 162), Peri-Guard®(K98(K042026). Hernia Patch SurgiSISTM (K98043 I) and Bard's® CK Parastornal In… | 2004 |
| * | K980431 | Surgisis | 1998 |
| * | — | Peri-Guard® Named without a submission number |
What descends from it? (74)
See all 745 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 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K050355 (Tissue Science Laboratories, Plc, 2005) has gone furthest, with 54 descendants of its own.
- 7 other devices also cite its predicate K992556.
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 of 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 wall defects and hernias, including but not limited to parastomal hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043366 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043366: 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/K043366
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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