510(k) · Cleared
ClearedLUOFUCON Silicone Ag Foam Dressing with Border
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 30, 2017 as substantially equivalent to K100029 (Molnlycke Health Care, 2010) and 1 other predicate after an 80-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 30, 2017
- Review
- 80 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K914579 (1992). 25 ancestors in all, the oldest K871166 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 4 generations backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- 3 generations backK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- 2 generations backK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- 1 generation backK160022 LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016
- This deviceK170077 LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON®…Huizhou Foryou Medical Devices Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See all- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · cites it directly1descendant
- K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −4 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| −3 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | Huizhou Foryou Medical Devices Co., Ltd. | 2017 | — |
| +1 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +2 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
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 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K100029 | Mepilex Border AG DressingSummary page 5…roduct Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery; 4. Predicate Device Identification: First: 510(k) Number: K100029 Product Name: Mepilex Border Ag Dressing Manufacturer: Mölnlycke Health Care Second: 510(k)… | 2010 |
| * | K160022 | LUOFUCON Silicone Ag foam dressingSummary page 5…First: 510(k) Number: K100029 Product Name: Mepilex Border Ag Dressing Manufacturer: Mölnlycke Health Care Second: 510(k) Number: K160022 Product Name: LUOFUCON® Silicone Ag Foam Dressing Manufacturer: Huizhou Foryou Medical Devices Co… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | 2024 | 1 |
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 25 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K223360 (Huizhou Foryou Medical Devices Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K100029.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® Silicone Ag Foam Dressing with Border is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns.
Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170077: LUOFUCON Silicone Ag Foam Dressing with Border.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170077
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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