510(k) · Cleared
ClearedMedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcu Technologies, Ltd. · FRO Dressing, Wound, Drug
Cleared on Nov 23, 2018 as substantially equivalent to K143001 (Argentum Medical, 2014) and 1 other predicate after a 256-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Nov 23, 2018
- Review
- 256 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914579 (1992). 18 ancestors in all, the oldest K890354 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
- 2 generations backK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- 1 generation backK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
- This deviceK180643 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK231088 Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984208 | Silverlon Island Dressing, Silverlon Island Pad | Argentum International, LLC | 1999 | — |
| −2 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| −1 | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing | Argentum Medical | 2014 | — |
| 0 (this device) | K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) | Medcu Technologies, Ltd. | 2018 | — |
| +1 | K231088 | Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad DressingSummary page 5…o the following Predicate Devices: 3.1 Argentum Medical’s Silverlon® Wound Pad Dressing & Silverlon® Island Wound Dressing, cleared under 510(k) number K143001 at November 7, 2014; 3.2 ProCyte Corporation’s Lamin® Wet Dressing (Copper-Saline), cleared under 510(k) number… | 2014 |
| * | K964468 | Iamin Wet Dressing (Copper-Saline)Summary page 5…ng, cleared under 510(k) number K143001 at November 7, 2014; 3.2 ProCyte Corporation’s Lamin® Wet Dressing (Copper-Saline), cleared under 510(k) number K964468 at February 3, 1997. 4. DEVICE DESCRIPTION The MedCu Antibacterial Wound Dressings with Copper-Oxide are sterile, so… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231088 | Copper Foam Dressing (Prescription and OTC) | 2024 | 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 26 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K231088 (Roosin Medical Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143001.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows: Over-The-Counter (OTC) use indications: Local management of superficial wounds, minor burns, abrasions and lacerations (tears).…
Read the full statement (121 words)
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to
provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct
contact with the wound. The dressings are intended to be used for indications as follows:
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Prescription use indications (Rx-only):
• Partial and full thickness wounds,
• Pressure ulcers (stage I-IV),
• Diabetic ulcers,
• Venous stasis ulcers,
• Arterial ulcers,
• 1st and 2nd degree burns,
• Surgical wounds,
• Vascular access or peripheral IV sites,
• Orthopedic external pin sites, and
• Acute wounds such as lacerations, abrasions, and skin tears.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180643: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180643
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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