510(k) · Cleared
ClearedCopa Amd Antimicrobial Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Group LP · FRO Dressing, Wound, Drug
Cleared on Nov 19, 2007 after a 187-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Nov 19, 2007
- Review
- 187 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK071371 Copa Amd Antimicrobial Wound DressingTyco Healthcare Group LP · 2007
- Descendant · cites it directly · 19 of its ownK111940 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012
- Descendant · 2 generations on · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
- Descendant · 3 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- Descendant · 4 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · 2 generations on · 3 of its ownK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012 · cites it directly19descendants
- K162764Jazz Frame SystemImplanet, S.A. · 2017 · 2 generations on6descendants
- K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 3 generations on5descendants
- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 4 generations on3descendants
- K173180Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071371 | Copa Amd Antimicrobial Wound Dressing | Tyco Healthcare Group LP | 2007 | — |
| +1 | K111940 | S 100 Pedicle Screw System | Renovis Surgical Technologies, LLC | 2012 | — |
| +2 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
| +3 | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| +4 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +2 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (3)
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 (Curafoam) polyurethane foam wound dressings Named without a submission number | |
| * | — | Kerlix AMID Named without a submission number | |
| * | — | Excilon AMID Named without a submission number |
What descends from it? (21)
See all 212 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, K111940 (Renovis Surgical Technologies, LLC, 2012) has gone furthest, with 19 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. 2007, 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/K071371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071371: Copa Amd 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/K071371
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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