510(k) · Cleared
ClearedFortaderm Antimicrobial Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · FRO Dressing, Wound, Drug
Cleared on Nov 8, 2005 as substantially equivalent to K011026 (Organogenesis, Inc., 2001) and 1 other predicate after a 140-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Nov 8, 2005
- Review
- 140 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970566 (1997). 9 ancestors in all, the oldest K895993 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 2 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- 1 generation backK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- This deviceK051647 Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK251582 Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261646 Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK093351 Collawound ArtCollamatrix, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026 · cites it directly1descendant
- K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K093351Collawound ArtCollamatrix, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −2 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| −1 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| 0 (this device) | K051647 | Fortaderm Antimicrobial Wound Dressing | Organogenesis, Inc. | 2005 | — |
| +1 | K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
| +2 | K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
| +1 | K093351 | Collawound Art | Collamatrix, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2026 | 2 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 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? (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 |
|---|---|---|---|
| * | K011026 | Fortaderm Wound Dressing | 2001 |
| * | K024054 | Xylos Xcell Antimicrobial DressingSummary page 1…e relevant predicate devices are FortaDermTM (PuraPlyT M ) Wound Dressing (KO11026) manufactured by Organogenesis, Inc. and Xcell Antimicrobial Cellulose Wound Dressing (K024054) manufactured by Xylos®Corporation. Statement of Substantial Equivalence: The FortaDermTM Antimicrobial PHMB Wound Dressing is s… | 2003 |
What descends from it? (3)
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 8 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K251582 (Beijing Kreate Medical Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K011026.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The FortaDermTM Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDermTM Antimicrobial PHMB Wound Dressing may be used for the management of: 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, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears) and draining wounds.
The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051647: Fortaderm Antimicrobial Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051647
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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