510(k) · Cleared
ClearedRedermax® Antibacterial Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Kreate Medical Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Aug 14, 2026 as substantially equivalent to K251582 (Beijing Kreate Medical Co., Ltd., 2026) after an 88-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Aug 14, 2026
- Review
- 88 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970566 (1997). 11 ancestors in all, the oldest K895993 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 4 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- 3 generations backK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- 2 generations backK051647 Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005
- 1 generation backK251582 Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
- This deviceK261646 Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −4 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| −3 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| −2 | K051647 | Fortaderm Antimicrobial Wound Dressing | Organogenesis, Inc. | 2005 | — |
| −1 | K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
| 0 (this device) | K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K251582 | Redermax Antibacterial Wound MatrixSummary page 5…Common Name: Antibacterial Wound Matrix Classification Unclassified Product Code: FRO Predicate Device: K251582, Redermax Antibacterial Wound Matrix Device Description Redermax® Antibacterial Wound Matrix is a sterile, single-use device in… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
Redermax Antibacterial Wound Matrix is intended for the management of wounds.
Redermax Antibacterial Wound Matrix is indicated 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-Mohs' surgery, post-laser surgery, podiatric,
wound dehiscence)
• Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
• Draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261646: Redermax® Antibacterial Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261646
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026