510(k) · Cleared
ClearedPolyver Silver Alginate Dressing (Prescription and OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roosin Medical Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Nov 17, 2023 as substantially equivalent to K041316 (Advanced Medical Solutions, Ltd., 2004) and 1 other predicate after a 297-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Nov 17, 2023
- Review
- 297 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914579 (1992). 15 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 2 generations backK120181 Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate…Huizhou Foryou Medical Devices Co., Ltd. · 2013
- 1 generation backK143335 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin…Roosin Medical Devices Co., Ltd. · 2015
- This deviceK230190 Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −2 | K120181 | Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing… | Huizhou Foryou Medical Devices Co., Ltd. | 2013 | — |
| −1 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate… | Roosin Medical Devices Co., Ltd. | 2015 | — |
| 0 (this device) | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K041316 | Antimicrobial Alginate DressingSummary page 4…duct Code: FRO Classification: Unclassified Review Panel: General & Plastic Surgery 5.0 Predicate Device Information: (1) K041316, “Silver Alginate II Dressing”, manufactured by “Advanced Medical Solutions Ltd”, located in Winsford, Cheshire, United Ki… | 2004 |
| * | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Summary page 4…formation: (1) K041316, “Silver Alginate II Dressing”, manufactured by “Advanced Medical Solutions Ltd”, located in Winsford, Cheshire, United Kingdom (2) K143335, “Roosin Silver Calcium Alginate Dressing/Roosin Antibacterial Calcium Alginate Dressing”, manufactured by “Roosin Medical… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 8 other devices also cite its predicate K041316.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Prescription Use:
“Polyver Silver Alginate Dressing” is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC Use:
First aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230190: Polyver Silver Alginate Dressing (Prescription and OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230190
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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