510(k) · Cleared
ClearedRoosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roosin Medical Devices Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Jun 1, 2015 as substantially equivalent to K120181 (Huizhou Foryou Medical Devices Co., Ltd., 2013) after a 193-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Jun 1, 2015
- Review
- 193 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914579 (1992). 14 ancestors in all, the oldest K890354 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 1 generation backK120181 Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate…Huizhou Foryou Medical Devices Co., Ltd. · 2013
- This deviceK143335 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin…Roosin Medical Devices Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK230190 Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −1 | K120181 | Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing… | Huizhou Foryou Medical Devices Co., Ltd. | 2013 | — |
| 0 (this device) | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate… | Roosin Medical Devices Co., Ltd. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K120181 | Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Summary page 4…Classification Name: Dressing, wound, Drug Product Code: FRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery Predicate Device Information: 1 K120181: “Luofucon Silver Alginate Dressing (Prescription Use)/ Luofucon Antibacterial Alginate Dressing (OTC Use)”, manufactured by “Hui… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | 2023 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K230190 (Roosin Medical Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120181.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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:
Roosin 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:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143335: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143335
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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