Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRO — Predicate Candidate Screening
705 FDA 510(k) clearances under this product code; the 50 most recent screened below.
148 daysmedian FDA review time
351 days90th percentile
705clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 | 86 | 0 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 | 366 | 0 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 | 30 | 0 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 | 146 | 0 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 | 105 | 0 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 | 268 | 0 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 | 259 | 0 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 | 254 | 0 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 | 255 | 0 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 | 162 | 0 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 | 293 | 0 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 | 132 | 0 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 | 210 | 0 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 | 162 | 0 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bot | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 | 260 | 0 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 | 271 | 0 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 | 115 | 0 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 | 331 | 0 |
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025-07-22 | 263 | 0 |
| K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | 2025-06-09 | 60 | 0 |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | 2025-05-02 | 176 | 0 |
| K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | 2025-04-21 | 125 | 0 |
| K242406 | SiOxC Cream | Sioxmed, LLC | 2025-03-13 | 211 | 0 |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 | 161 | 0 |
| K240809 | LUOFUCON® Silver Collagen Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 | 266 | 0 |
| K242758 | Atrauman® Ag | Hartmann USA, Inc. | 2024-12-09 | 88 | 0 |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUO | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 | 54 | 0 |
| K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. | 2024-11-08 | 260 | 0 |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024-10-31 | 31 | 0 |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 | Speciality Fibres and Materials, Ltd. | 2024-10-21 | 773 | 0 |
| K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024-10-17 | 1212 | 0 |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescrip | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 | 230 | 0 |
| K240722 | Derma-R Cream (Derma-R Cream) | Raya Pharmaceuticals, LLC | 2024-09-20 | 186 | 0 |
| K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024-09-13 | 345 | 0 |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024-08-21 | 202 | 0 |
| K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024-07-31 | 90 | 0 |
| K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2024-07-19 | 28 | 0 |
| K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024-07-18 | 1073 | 0 |
| K240552 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2024-06-18 | 111 | 0 |
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2024-05-31 | 323 | 0 |
| K232333 | Anti-bacterial bandage | Jinhua Jingdi Medical Supplies Co., Ltd. | 2024-05-31 | 301 | 0 |
| K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound | Foshan United Medical Technologies, Ltd. | 2024-05-24 | 240 | 0 |
| K232655 | Bonvadis® | Stemcyte, Inc. | 2024-05-22 | 265 | 0 |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ | Huizhou Foryou Medical Devices Co., Ltd. | 2024-03-27 | 510 | 0 |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® B | Medline Industries, LP | 2024-03-26 | 181 | 0 |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatai | Coloplast Corp. | 2024-03-22 | 266 | 0 |
| K231088 | Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2024-01-11 | 269 | 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 |
| K231057 | Antibacterial Gel Wound Dressing | Winner Medical Co., Ltd. | 2023-12-01 | 232 | 0 |
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