510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K904330 | Turbo-Rast Specific Ige Assay | Ventrex Laboratories, Inc. | DHB | Class II | |
| K904279 | Paroject Anesthetic Syringe | Ronvig Instruments, Ltd. | EGM | Class II | |
| K904203 | Surgilase Sl 50/60 Gold Surgical Laser System | Surgilase, Inc. | GEX | Class II | |
| K903790 | Endoscopic Light Source 250 Endo | Orlux Engineering and Instrumentation | FCW | Class II | |
| K902809 | Bracket, Metal, Orthodotnic | Masel Industries, Inc. | EJF | Class I | |
| K902740 | Ldl-Direct Controls | Isolab, Inc. | JJY | Class I | |
| K902488 | Modified Cass System | Medical Instrumentation & Diagnostics Corp.(Midco) | KXK | Class II | |
| K902225 | Childrens Sunglasses | Jasco Products Co., Inc. | HQY | Class I | |
| K900404 | Varicoscreen(tm) | Promedex, Inc. | KYA | Class I | |
| K905293 | System 90 and 95 | Folio Products, Inc. | ITI | Class II | |
| K905098 | Elegance Gh Elisa | Bioclone Australia Pty, Ltd. | CFL | Class I | |
| K904968 | Qclyte Protein Based Ise Control | Baxter Healthcare Corporation | JJY | Class I | |
| K904829 | Acs Cholesterol/triglyceride Liquid Control | Analytical Control Systems | JJY | Class I | |
| K904819 | Shur-Lock Ice Wrap System | Conco Medical Co. | IMD | Class I | |
| K904782 | Answer Quick and Simple at-Home Pregnancy Test | Carter Products | LCX | Class II | |
| K904477 | Guidewire | Datascope Corp. | DQX | Class II | |
| K904171 | Scimed Cardiotherm Cardioplegia Delivery System | Scimed | DTR | Class II | |
| K904143 | V. Mueller Trocars/trocar Sleeves & Needles | Baxter Healthcare Corporation | HET | Class II | |
| K904075 | Clinical Chemistry Control | Phoenix Diagnostics, Inc. | JJY | Class I | |
| K904040 | Softshell Venous Reservoir | C.R. Bard Inc | DTN | Class II | |
| K903931 | Gore-Tex(r) Stretch Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K903740 | Trach-Eze | Sorex Medical | BSY | Class I | |
| K904980 | Dpx-L and Dpx-Alpha, Modification | Lunar Corp. | KGI | Class II | |
| K904921 | Steri-Vac(tm) Aerator Model Xl | 3M Company | FLI | Class II | |
| K904919 | Proximal Femur Replacement Stem | Depuy, Inc. | JDI | Class II | |
| K904896 | Eye Pad | Ulti-Med Intl., Inc. | HMP | Class I | |
| K904844 | Precision Hip Stem with Additional Stem Sizes | Howmedica Corp. | JDI | Class II | |
| K904417 | Chemosite Implantable Drug Delivery System | Device Labs, Inc. | LJT | Class II | |
| K904296 | Lysta Hygienist III Scaler | Prodent Intl., Inc. | ELC | Class II | |
| K904284 | Arthroscopic Surgical Blade | Smith & Nephew Dyonics, Inc. | HRX | Class II | |
| K904199 | Horizon Regular Etching Gel | Horizon Chemical Co. | EJR | Class I | |
| K904183 | Site Phacoemulsification Handpiece | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K904151 | Site 19 Gauge Ultrasonic I/a Phaco Needle | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K904142 | Grasping Forceps/aligator Forceps/needle Holders | Baxter Healthcare Corporation | HET | Class II | |
| K904104 | Endopath Unshielded Disposable Surgical Trocar | Ethicon, Inc | HET | Class II | |
| K904050 | Model Dh-1000 Single Detec./dual Detec Nucl Camera | Philips North America LLC | IYX | Class I | |
| K903722 | Micromed Qrs Card | Nasiff Assoc., Inc. | DPS | Class II | |
| K903672 | Dene Bridge | Dirotian Pty., Ltd. | EKO | Class II | |
| K903461 | Tsrh Offset and Side-Loading Hooks | Danek Medical, Inc. | KWP | Class II | |
| K903417 | Vas-Cath Opti-Plast 5F Peripheral Angioplasty Cath | Vas-Cath, Inc. | LIT | Class II | |
| K903346 | Disposable Emissions Barrier Laser Drape | Wave-Form Systems, Inc. | KKX | Class II | |
| K902724 | Advance Disposable Stopcock | Advance Medical Designs Inc | FMG | Class II | |
| K900932 | 37-702 and 37-703 Pc Rainbow | Victoreen, Inc. | IYI | Class II | |
| K900464 | Mic Percutaneous Endoscopic Gastrostomy Tube | Medical Innovations, Inc. | KNT | Class II | |
| K905245 | Sports Rider and Shop Rider | National Health Services, Inc. | INI | Class II | |
| K905079 | Ortho Rubella-M Antibody Elisa Test | Ortho Diagnostic Systems, Inc. | LFX | Class II | |
| K904986 | Programmable Video Controller Model Pk2060 | Perkins Mfg. Co. | JAA | Class II | |
| K904854 | Rubeola Igg Elisa Test | Gull Laboratories, Inc. | LJB | Class I | |
| K904773 | P and T Medium | Microbiologics, Inc. | JTW | Class I | |
| K904515 | Impraflo 3500 Series | Impra, Inc. | CAC | Class II |