Huizhou Foryou Medical Devices Co., Ltd.: FDA clearances and approvals
Huizhou Foryou Medical Devices Co., Ltd. has 23 FDA 510(k) clearances (first 2012, latest 2026), across 7 product codes in 4 review panels. Median 510(k) review time: 260 days. Since 2017 its median was 260 days, against 162 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 239 |
| 2013 | 2 | 222 |
| 2014 | 0 | — |
| 2015 | 2 | 318 |
| 2016 | 1 | 225 |
| 2017 | 1 | 80 |
| 2018 | 2 | 182 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 262 |
| 2022 | 3 | 372 |
| 2023 | 1 | 413 |
| 2024 | 6 | 248 |
| 2025 | 1 | 260 |
| 2026 | 1 | 232 |
Review time against the same product codes
Since 2017, Huizhou Foryou Medical Devices Co., Ltd.'s cleared 510(k)s took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 16 | 16 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| OLR | Oral Wound Dressing | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
| QSZ | Absorbable Synthetic Wound Dressing | 1 | 1 |
Review panels
- General and Plastic Surgery (20)
- Dental (1)
- General Hospital (1)
- Ophthalmic (1)
Most recent Huizhou Foryou Medical Devices Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254256 | LUOFUCON® Wound Matrix | QSZ | 2026-08-18 | 232 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | FRO | 2025-11-19 | 260 |
| K240809 | LUOFUCON® Silver Collagen Dressing | FRO | 2024-12-16 | 266 |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | FRO | 2024-11-13 | 54 |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | FRO | 2024-10-07 | 230 |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | 2024-04-25 | 226 |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | FRO | 2024-03-27 | 510 |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | FRO | 2024-01-04 | 629 |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | FRO | 2023-12-21 | 413 |
| K213598 | LUOFUCON Collagen Wound Dressing | KGN | 2022-09-20 | 309 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Huizhou Foryou Medical Devices Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Huizhou Foryou Medical Devices Co., Ltd. have?
Huizhou Foryou Medical Devices Co., Ltd. has 23 FDA 510(k) clearances (first 2012, latest 2026), across 7 product codes in 4 review panels.
How long does FDA take to clear Huizhou Foryou Medical Devices Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Huizhou Foryou Medical Devices Co., Ltd.'s cleared 510(k)s is 260 days. Since 2017: 260 days, versus 162 days for all cleared 510(k)s in the same product codes.
What devices does Huizhou Foryou Medical Devices Co., Ltd. make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 16); KGN (Wound Dressing With Animal-Derived Material(S), 2); FXX (Mask, Surgical, 1).
Has Huizhou Foryou Medical Devices Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Huizhou Foryou Medical Devices Co., Ltd. Related entities may recall under other names.
Next steps
- See all 23 Huizhou Foryou Medical Devices Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Huizhou Foryou Medical Devices Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.