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 |
|---|---|---|---|---|---|
| K951696 | Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K951083 | Proform Cemented Femoral Component | Globus Medical, Inc. | JDG | Class II | |
| K950800 | Pro-Pak for Oms Diplomate | M. Imonti and Associates Inc. | HQC | Class II | |
| K950798 | Posterior Capsule Shield | Oasis Medical, Inc. | HQC | Class II | |
| K950594 | Hemi-Shoulder Prosthesis | Encore Orthopedics, Inc. | HSD | Class II | |
| K950483 | Hewlett Packard M2475b Codemaster 100 Defibrillator/monitor | Hewlett-Packard Co. | DRO | Class II | |
| K950384 | Synthes(usa) Synthes Hybrid External Fixator | Synthes (USA) Products LLC | LXT | Class II | |
| K950070 | Mitek Toggle Anchor(tm) | Mitek Surgical Products, Inc. | JDR | Class II | |
| K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America Inc | GWQ | Class II | |
| K941722 | Fna Biopsy Needle | Betta Medical, Inc. | FCG | Class II | |
| K940273 | Nobles-Lai Video Imaging System | Visioneering, Inc. | GWG | Class II | |
| K936159 | Natural-Knee II System | Intermedics Orthopedics | JWH | Class II | |
| K935802 | Select(r) Shoulder All Poly Glenoid | Intermedics Orthopedics | KWS | Class II | |
| K935080 | Insall-Burstein II | Hospital for Special Surgery | JWH | Class II | |
| K931265 | Fixano Total Trapezio Metacarpal Prosthesis, 2Nd | Ferguson Medical | JWI | Class II | |
| K952009 | Prima Pediatric Temperature Monitoring Circuits | Prima, Inc. | CAI | Class I | |
| K951874 | Strato/infusaid Macroport Vascular Acc. System | Strato/Infusaid, Inc. | LJT | Class II | |
| K951873 | Strato/infusaind Microport Vascular Acc. System | Strato/Infusaid, Inc. | LJT | Class II | |
| K951295 | Sterrad Sterilization Pouch | Advanced Sterilization Products | KCT | Class II | |
| K951064 | Disposable Wound Measure Guide, Plastic, Protector, Wound, Plastic | S-E Sales & Distribution, Inc. | FTY | Class I | |
| K950852 | Cutter, Vitreous Anterior Vitrectomy Probe (Avp) | H.S. Intl. Co., Inc. | HQE | Class II | |
| K950394 | Tibia-Talus-Calcaneus Nail | Smith & Nephew Richards, Inc. | HSB | Class II | |
| K946276 | Quickvue(r) Chlamydia Test | Ortho-Clinical Diagnostics, Inc. | LJC | Class I | |
| K945904 | Scimed(r) Venture(tm) II Infusion Catheter | Scimed Peripheral Interventions | KRA | Class II | |
| K945797 | Sterile Empty Pca Syringe | Intl. Medication Systems, Ltd. | FMF | Class II | |
| K945065 | Dideco Flexible Reservoir -- Product Designation 5063 | Sorin Biomedical, Inc. | DTN | Class II | |
| K945053 | Lf CT Hig Pressure Catheters | Mallinckrodt Group, Inc. | FOZ | Class II | |
| K944937 | Synthetic Absorbable Suture | Johnson & Johnson International | GAM | Class II | |
| K942050 | Hemolab Cofac IX | Biomerieux Vitek, Inc. | GJT | Class II | |
| K942049 | Biomerieux Hemolab Cofac II | Biomerieux Vitek, Inc. | GJT | Class II | |
| K941462 | Cardiovit at-5C | Schiller America, Inc. | LOS | ||
| K940615 | Accutest | Instrumed, Inc. | KCY | Class I | |
| K935807 | Access(r) Chlamydia Eia and Blocking Assay | Bio-Rad Laboratories Inc. | LJC | Class I | |
| K935525 | Phototherapeutix Model 2480Ab | Avex Industries, Ltd. | FTC | Class II | |
| K935471 | Filtryzer(tm) | Toray Industries (America), Inc. | FJI | Class II | |
| K933523 | i.v. Filter Set | Mediziv Medical Products 1987, Ltd. | FPB | Class II | |
| K930578 | At33 EMG | Autoject Systems, Inc. | HCC | Class II | |
| K930272 | Hemagen Chagas' Kit (Eia Method) | Hemagen Diagnostics, Inc. | MIU | Class I | |
| K951872 | Strato/infusaid Dualport Vascular Acc. System | Strato/Infusaid, Inc. | LJT | Class II | |
| K951492 | Rib Resector | United States Surgical, A Division of Tyco Healthc | HAO | Class I | |
| K951287 | Axsym Opiates | Abbott Medical | DJG | Class II | |
| K951253 | Axsym Barbiturates II U | Abbott Medical | DIS | Class II | |
| K951234 | Medical Support Stockings | Jobst A Beiersdorf Co. | DWL | Class II | |
| K945631 | 155 Sce(tm) Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | FJI | Class II | |
| K945624 | Mca(tm) 160 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | FJI | Class II | |
| K945623 | Mca(tm) 130 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | FJI | Class II | |
| K945620 | Altra Flux(tm) 140 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | KDI | Class II | |
| K943541 | 75K Staight Drill | Stryker Corp. | HBE | Class II | |
| K942858 | Latex Condoms W/spermicidal Lubricant (Nonoxynol-9) | Suretex, Ltd. | HIS | Class II | |
| K930577 | At64 Scr | Autoject Systems, Inc. | HCC | Class II |