510(k) · Cleared
ClearedPHMB 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 Aug 3, 2018 as substantially equivalent to K163062 (Advanced Medical Solutions, Ltd., 2017) after an 88-day review. Its family tree reaches back 1 generation to 2017. 5 later devices descend from it.
- Decided
- Aug 3, 2018
- Review
- 88 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K163062 (2017). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK163062 PHMB Antimicrobial Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2017
- This deviceK181197 PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK192463 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive…Winner Medical Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK190819 Silicone PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK213473 Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223310 Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited · 2023
- Descendant · 2 generations on · 0 of its ownK221532 PHMB Wound DressingWinner Medical Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam…Winner Medical Co., Ltd. · 2020 · cites it directly1descendant
- K190819Silicone PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. · 2019 · cites it directly1descendant
- K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023 · cites it directly0descendants
- K223310Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited · 2023 · 2 generations on0descendants
- K221532PHMB Wound DressingWinner Medical Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K163062 | PHMB Antimicrobial Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2017 | — |
| 0 (this device) | K181197 | PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2018 | — |
| +1 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB… | Winner Medical Co., Ltd. | 2020 | — |
| +1 | K190819 | Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2019 | — |
| +1 | K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. | 2023 | — |
| +2 | K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | 2023 | — |
| +2 | K221532 | PHMB Wound Dressing | Winner Medical Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K163062 | PHMB Antimicrobial Foam Wound DressingSummary page 4…Dressing, Wound, Drug Classification: Unclassified (Pre-amendment) Classification Code: Product code: FRO Predicate Device(s): PHMB Foam Wound Dressing (K163062) Reference Device(s): Kendall™ AMD Antimicrobial Wound Dressing (K082296)… | 2017 |
| † | K082296 | Copa Amd | 2009 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K192463 (Winner Medical Co., Ltd., 2020) has gone furthest, with 1 descendant 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. 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?
PHMB Foam Wound Dressings are indicated for use in the 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/K181197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181197: PHMB 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/K181197
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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