510(k) · Cleared
ClearedLUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
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 May 1, 2018 as substantially equivalent to K120181 (Huizhou Foryou Medical Devices Co., Ltd., 2013) after a 250-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- May 1, 2018
- Review
- 250 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). 3 later devices descend from it, 2 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 deviceK172554 LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra…Huizhou Foryou Medical Devices Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK202982 Silver Alginate Dressing (Prescription use), Antibacterial Alginate…Winner Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK220673 Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK201016 LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB…Huizhou Foryou Medical Devices Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd. · 2021 · cites it directly1descendant
- K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd. · 2023 · 2 generations on0descendants
- K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd. · 2021 · 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) | K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate… | Huizhou Foryou Medical Devices Co., Ltd. | 2018 | — |
| +1 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would… | Winner Medical Co., Ltd. | 2021 | — |
| +2 | K220673 | Sterile Silver Alginate Wound Dressing | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2023 | — |
| +1 | K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate… | Huizhou Foryou Medical Devices Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 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…d, Drug; Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery; 4. Predicate Device Identification: 510(k) Number: K120181 Product Name: LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dr… | 2013 |
What descends from it? (3)
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 26 years and passes through 4 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, K202982 (Winner Medical Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 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?
Luofucon Extra 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.
Luofucon Antibacterial Alginate Wound Dressing is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172554: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172554
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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