510(k) · Cleared
ClearedSis Wound Dressing II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 6, 2000 as substantially equivalent to K973170 (Cook Biotech, Inc., 1998) and 3 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1988. 235 later devices descend from it.
- Decided
- Jan 6, 2000
- Review
- 45 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K881854 (1988). 7 ancestors in all. 235 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 1 generation backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- This deviceK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · 2 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
- Descendant · 3 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
- Descendant · cites it directly · 53 of its ownK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
Showing 5 of 235 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 235 · See all- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
- K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
- K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 2 generations on91descendants
- K042809CuffpatchOrganogenesis, Inc. · 2004 · 3 generations on72descendants
- K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −1 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| 0 (this device) | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| +1 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +2 | K031969 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2003 | — |
| +3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| +1 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 8 | 0 |
| 2007 | 11 | 0 |
| 2008 | 11 | 0 |
| 2009 | 13 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 12 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 16 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 0 |
| 2026 | 13 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K973170 | Sis Wound DressingSummary page 1…Wound Dressing !l is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing (D.C. #K973170) manufactured by Cook Biotech, Incorporated, the FIBRACOL * Plus Collagen Wound Dressing with Alginate (D.C. #K982597) manufactur… | 1998 |
| * | K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateSummary page 1…t of wounds including the SIS Wound Dressing (D.C. #K973170) manufactured by Cook Biotech, Incorporated, the FIBRACOL * Plus Collagen Wound Dressing with Alginate (D.C. #K982597) manufactured by Johnson and Johnson Medical, and the SkinTemp® Koliagen Wound Management Material (D.C. #K913023) and Medifil® K… | 1998 |
| * | K913023 | SkintempSummary page 1…COL * Plus Collagen Wound Dressing with Alginate (D.C. #K982597) manufactured by Johnson and Johnson Medical, and the SkinTemp® Koliagen Wound Management Material (D.C. #K913023) and Medifil® Kollagen Particles (D.C. #K910944) manufactured by Biocore Medical Technologies. Device Description: The SIS Wound… | 1991 |
| * | K910944 | MedifilSummary page 1…(D.C. #K982597) manufactured by Johnson and Johnson Medical, and the SkinTemp® Koliagen Wound Management Material (D.C. #K913023) and Medifil® Kollagen Particles (D.C. #K910944) manufactured by Biocore Medical Technologies. Device Description: The SIS Wound Dressing |l is primarily composed of porcine co… | 1991 |
What descends from it? (235)
See all 23510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | 2000 | 173 |
| K021792 | Bilayer Matrix Wound Dressing | 2002 | 53 |
| K021637 | Acell Ubm Lyophilized Wound Dressing | 2002 | 45 |
| K023778 | Dressskin | 2003 | 31 |
| K022127 | Avagen Wound Dressing | 2002 | 28 |
| K092096 | Endoform Dermal Template | 2010 | 19 |
| K020732 | SS Matrix | 2002 | 5 |
| K090894 | Collawound Wound Dressing | 2009 | 2 |
| K040314 | Healicoll | 2004 | 0 |
| K022854 | Acell Ubm Hydrated Wound Dressing | 2002 | 0 |
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 10.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K001738 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 173 descendants of its own.
- 2 other devices also cite its predicate K973170.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
The SIS Wound Dressing Il is intended for the management of wounds including:
Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic vascular ulcers
Tunneled/undermined wounds
Surgical wounds (donor sites/grafts, post-moh’s surgery, post-laser surgery, podiatric, wound dehiscence)
Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
Draining wounds.
The device is intended for one-time use.
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/K993948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993948: Sis Wound Dressing II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993948
Report an extraction error
Are you the manufacturer?
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