510(k) · Cleared
ClearedLufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM, Lufucon Silver Dressing 200X100MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huizhou Foryou Medical Devices Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Feb 14, 2013 as substantially equivalent to K041316 (Advanced Medical Solutions, Ltd., 2004) and 1 other predicate after a 391-day review. Its family tree reaches back 4 generations to 1992. 6 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 391 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914579 (1992). 13 ancestors in all, the oldest K890354 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- This deviceK120181 Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate…Huizhou Foryou Medical Devices Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK172554 LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra…Huizhou Foryou Medical Devices Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK202982 Silver Alginate Dressing (Prescription use), Antibacterial Alginate…Winner Medical Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK143335 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin…Roosin Medical Devices Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK230190 Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK220673 Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd. · 2018 · cites it directly3descendants
- K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd. · 2021 · 2 generations on1descendant
- K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd. · 2015 · cites it directly1descendant
- K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. · 2023 · 2 generations on0descendants
- K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| 0 (this device) | K120181 | Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing… | Huizhou Foryou Medical Devices Co., Ltd. | 2013 | — |
| +1 | K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate… | Huizhou Foryou Medical Devices Co., Ltd. | 2018 | — |
| +2 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would… | Winner Medical Co., Ltd. | 2021 | — |
| +1 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate… | Roosin Medical Devices Co., Ltd. | 2015 | — |
| +2 | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2023 | — |
| +3 | K220673 | Sterile Silver Alginate Wound Dressing | Qingdao Bright Moon Biomedical Materials 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (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 1…Product Code: PRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery Predicate Device Information: (1) K0413 16, "Silver Alginate 11 Dressing", manufactured by "Advanced Medical Solutions, Inmc" located in Cheshire, England CW7 3PD… | 2004 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…evice Information: (1) K0413 16, "Silver Alginate 11 Dressing", manufactured by "Advanced Medical Solutions, Inmc" located in Cheshire, England CW7 3PD (2) K0236 12, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentumn Medical LLC" located in Lakemont, Georgia 3055… | 2003 |
What descends from it? (6)
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)
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 21 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K172554 (Huizhou Foryou Medical Devices Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 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. 2013, 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?
OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and bums.
Prescription:
Luofucon 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120181: Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM, Lufucon Silver Dressing 200X100MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120181
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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