Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Huizhou Foryou Medical Devices Co., Ltd. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
413 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bot | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 | 260 | 0 |
| K240809 | LUOFUCON® Silver Collagen Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 | 266 | 0 |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUO | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 | 54 | 0 |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescrip | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 | 230 | 0 |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-04-25 | 226 | 0 |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ | Huizhou Foryou Medical Devices Co., Ltd. | 2024-03-27 | 510 | 0 |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON An | Huizhou Foryou Medical Devices Co., Ltd. | 2024-01-04 | 629 | 0 |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foa | Huizhou Foryou Medical Devices Co., Ltd. | 2023-12-21 | 413 | 0 |
| K213598 | LUOFUCON Collagen Wound Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2022-09-20 | 309 | 0 |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wou | Huizhou Foryou Medical Devices Co., Ltd. | 2022-04-22 | 372 | 0 |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silve | Huizhou Foryou Medical Devices Co., Ltd. | 2022-03-23 | 378 | 0 |
| K201852 | Surgical Mask-Model Number: Ear Loop, Flat-Pleated | Huizhou Foryou Medical Devices Co., Ltd. | 2021-03-02 | 239 | 0 |
| K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Anti | Huizhou Foryou Medical Devices Co., Ltd. | 2021-01-28 | 286 | 0 |
| K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Anti | Huizhou Foryou Medical Devices Co., Ltd. | 2018-05-01 | 250 | 0 |
| K173196 | SUNTOUCH Dental Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2018-01-24 | 114 | 0 |
| K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | Huizhou Foryou Medical Devices Co., Ltd. | 2017-03-30 | 80 | 0 |
| K160022 | LUOFUCON Silicone Ag foam dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2016-08-17 | 225 | 0 |
| K141619 | LUOFUCON SILVER FOAM DRESSING | Huizhou Foryou Medical Devices Co., Ltd. | 2015-04-06 | 293 | 0 |
| K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | Huizhou Foryou Medical Devices Co., Ltd. | 2015-03-23 | 343 | 0 |
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | 2013-10-30 | 54 | 0 |
| K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALG | Huizhou Foryou Medical Devices Co., Ltd. | 2013-02-14 | 391 | 0 |
| K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | Huizhou Foryou Medical Devices Co., Ltd. | 2012-05-23 | 239 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda