510(k) · Cleared
Recalled · Class III · 2022Silver High Performance 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 May 29, 2019 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) after a 154-day review. Its family tree reaches back 4 generations to 1992. 4 later devices descend from it. It has been recalled once.
- Decided
- May 29, 2019
- Review
- 154 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914604 (1992). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- This deviceK183645 Silver High Performance DressingAdvanced Medical Solutions, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK210718 LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver…Huizhou Foryou Medical Devices Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK240485 LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK221110 LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK210974 High Performance Antimicrobial Gelling Fiber with SilverAdvanced Medical Solutions, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…Huizhou Foryou Medical Devices Co., Ltd. · 2022 · cites it directly2descendants
- K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on0descendants
- K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on0descendants
- K210974High Performance Antimicrobial Gelling Fiber with SilverAdvanced Medical Solutions, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −3 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −2 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| 0 (this device) | K183645 | Silver High Performance Dressing | Advanced Medical Solutions, Ltd. | 2019 | — |
| +1 | K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
| +2 | K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +2 | K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +1 | K210974 | High Performance Antimicrobial Gelling Fiber with Silver | Advanced Medical Solutions, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 4…sing, Wound, Drug Classification: Unclassified (Pre-amendment) Classification Code: Product code: FRO Predicate Device(s): AQUACEL® Ag Hydrofiber Dressing (K080383) Certificate No. MD78010… | 2008 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1806-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K210718 (Huizhou Foryou Medical Devices Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K080383.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of
moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds:
• Pressure ulcers (partial and full thickness)
• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• Diabetic foot ulcers
• Surgical wounds that heal by primary intent such as dermatological and surgical incisions
• Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
• Traumatic wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183645: Silver High Performance Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183645
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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