510(k) · Cleared
ClearedLuofucon Silver PU Antibacterial Foam 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 Mar 23, 2015 as substantially equivalent to K100218 (Coloplast A/S, 2010) after a 343-day review. Its family tree reaches back 6 generations to 1992. 5 later devices descend from it.
- Decided
- Mar 23, 2015
- Review
- 343 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 21 ancestors in all, the oldest K871166 (1987). 5 later devices descend from it, 2 citing it directly.
- 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 backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 2 generations backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- 1 generation backK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- This deviceK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK160022 LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK170077 LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON®…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016 · cites it directly3descendants
- K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017 · 2 generations on2descendants
- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · 3 generations on1descendant
- K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 4 generations on0descendants
- K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023 · cites it directly0descendants
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 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −2 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| −1 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| 0 (this device) | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +1 | K160022 | LUOFUCON Silicone Ag foam dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2016 | — |
| +2 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | Huizhou Foryou Medical Devices Co., Ltd. | 2017 | — |
| +3 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +4 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +1 | K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMSummary page 5…s, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, post-operative wounds and skin abrasions. 5. Predicate Device Identification 510(k) Number: K100218 Product Name: Biatain Ag Foam Dressings Manufacturer: Coloplast A/S 6. Device Description The proposed device, LUOFUCON" Silver… | 2010 |
What descends from it? (5)
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 23 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K160022 (Huizhou Foryou Medical Devices Co., Ltd., 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K100218.
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?
LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, post-operative wounds and skin abrasions.
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/K140954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140954: Luofucon Silver PU Antibacterial Foam Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140954
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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