510(k) · Cleared
ClearedLUOFUCON® Silver Collagen 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 Dec 16, 2024 as substantially equivalent to K071552 (Medline Industries, Inc., 2008) after a 266-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Dec 16, 2024
- Review
- 266 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071552 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK071552 Puracol Plus AG Collagen Microscaffold Wound DressingMedline Industries, Inc. · 2008
- This deviceK240809 LUOFUCON® Silver Collagen DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071552 | Puracol Plus AG Collagen Microscaffold Wound Dressing | Medline Industries, Inc. | 2008 | — |
| 0 (this device) | K240809 | LUOFUCON® Silver Collagen Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K071552 | Puracol Plus AG Collagen Microscaffold Wound DressingSummary page 5…Predicate device: The Name of Device: Puracol® Plus Ag MicroScaffold™ Wound Dressing Trade name: Puracol Plus Ag Collagen Wound Dressing 510(K) Number: K071552 Submitter: Medline Industries, Inc. Manufacturer: Medskin Solutions Classification Name: Dressing, Wound, Drug… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K071552.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Collagen Dressing is intended for the management of wounds that include:
Full thickness and partial thickness wounds
Pressure ulcers
venous ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
First and second degree burns
Donor sites and other bleeding surface wounds
Abrasions
Trauma wounds healing by secondary intention
Dehisced wounds
Surgical wounds
Dehisced surgical wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240809: LUOFUCON® Silver Collagen Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240809
Report an extraction error
Are you the manufacturer?
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