510(k) · Cleared
ClearedPHMB Antimicrobial Foam Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Solutions, Ltd. · FRO Dressing, Wound, Drug
Cleared on Jul 25, 2017 after a 265-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Jul 25, 2017
- Review
- 265 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK163062 PHMB Antimicrobial Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2017
- Descendant · cites it directly · 5 of its ownK181197 PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK192463 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive…Winner Medical Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK190819 Silicone PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK213473 Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK223310 Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181197PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2018 · cites it directly5descendants
- K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam…Winner Medical Co., Ltd. · 2020 · 2 generations on1descendant
- K190819Silicone PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2019 · 2 generations on1descendant
- K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023 · 2 generations on0descendants
- K223310Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K163062 | PHMB Antimicrobial Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2017 | — |
| +1 | K181197 | PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2018 | — |
| +2 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB… | Winner Medical Co., Ltd. | 2020 | — |
| +2 | K190819 | Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2019 | — |
| +2 | K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. | 2023 | — |
| +3 | K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181197 | PHMB Foam Wound Dressing | 2018 | 5 |
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, K181197 (Advanced Medical Solutions, Ltd., 2018) has gone furthest, with 5 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. 2017, 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 | — |
https://510kreport.com/device/K163062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163062: PHMB Antimicrobial Foam 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/K163062
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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