510(k) · Cleared
ClearedCopa Amd
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS Tyco Healthcar · FRO Dressing, Wound, Drug
Cleared on Feb 26, 2009 after a 198-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Feb 26, 2009
- Review
- 198 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK082296 Copa AmdCovidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- Descendant · cites it directly · 4 of its ownK160872 PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK181315 Antimicrobial gauze sponge dressing, Antimicrobial super sponge…Winner Medical Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge…Winner Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK201016 LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB…Huizhou Foryou Medical Devices Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK183681 Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160872PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016 · cites it directly4descendants
- K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…Winner Medical Co., Ltd. · 2019 · 2 generations on1descendant
- K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd. · 2023 · 3 generations on0descendants
- K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd. · 2021 · cites it directly0descendants
- K183681Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082296 | Copa Amd | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| +1 | K160872 | PolyPlex Wound Dressing | Global Health Solutions, LLC | 2016 | — |
| +2 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2019 | — |
| +3 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2023 | — |
| +1 | K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate… | Huizhou Foryou Medical Devices Co., Ltd. | 2021 | — |
| +2 | K183681 | Protego Antimicrobial Wound Dressing | Global Health Solutions (Dba Turn Therapeutics) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | COPA AMD antimicrobial wound dressing Named without a submission number |
What descends from it? (6)
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?
- Of its descendants, K160872 (Global Health Solutions, LLC, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082296: Copa Amd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082296
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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