510(k) · Cleared
ClearedPolyPlex Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Health Solutions, LLC · FRO Dressing, Wound, Drug
Cleared on Nov 23, 2016 as substantially equivalent to K082296 (Covidien Lp, Formerly Registered AS Tyco Healthcar, 2009) and 1 other predicate after a 238-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Nov 23, 2016
- Review
- 238 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K041013 (2004). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK041013 Suile Ointment Wound DressingHedonist Biochemical Technologies Co., Ltd. · 2004
- This deviceK160872 PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016
- Descendant · cites it directly · 1 of its ownK181315 Antimicrobial gauze sponge dressing, Antimicrobial super sponge…Winner Medical Co., Ltd. · 2019
- Descendant · 2 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 ownK183681 Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019
- Descendant · cites it directly · 0 of its ownK171191 Hexagen DermGlobal Health Solutions, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…Winner Medical Co., Ltd. · 2019 · cites it directly1descendant
- K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd. · 2023 · 2 generations on0descendants
- K183681Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019 · cites it directly0descendants
- K171191Hexagen DermGlobal Health Solutions, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041013 | Suile Ointment Wound Dressing | Hedonist Biochemical Technologies Co., Ltd. | 2004 | — |
| 0 (this device) | K160872 | PolyPlex Wound Dressing | Global Health Solutions, LLC | 2016 | — |
| +1 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2019 | — |
| +2 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2023 | — |
| +1 | K183681 | Protego Antimicrobial Wound Dressing | Global Health Solutions (Dba Turn Therapeutics) | 2019 | — |
| +1 | K171191 | Hexagen Derm | Global Health Solutions, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010882 | FDA’s K010882 is Blue Sky Bio Dental Implant System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K082296 | Copa AmdSummary page 4…ication Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified 5. Predicate Device: Prontosan Wound Gel (K10882) Copa AMD Antimicrobial Wound Dressing (K082296) SuileOIntment Wound DRessing (K041013) 6. Description of Proposed Device: PolyPlex Wound Dressing is an amorphous, odorless, pe… | 2009 |
| * | K041013 | Suile Ointment Wound DressingSummary page 4…duct Code: FRO Device Class: Unclassified 5. Predicate Device: Prontosan Wound Gel (K10882) Copa AMD Antimicrobial Wound Dressing (K082296) SuileOIntment Wound DRessing (K041013) 6. Description of Proposed Device: PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion intended to mai… | 2004 |
What descends from it? (4)
3 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?
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160872: PolyPlex Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160872
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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