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 |
|---|---|---|---|---|---|
| K010845 | Modification to Osteonics Spinal System | Howmedica Osteonics Corp | MNH | Class II | |
| K010839 | Cls Varus Stem/cls 135 Stem | Sulzer Orthopedics, Inc. | LZO | Class II | |
| K010822 | Ab Cardiette Start 200 Hv | H&C Medical Devices SpA | DPS | Class II | |
| K010810 | Depuy Preservation Unicondylar Knee Prosthesis | Depuy Orthopaedics Inc. | HRY | Class II | |
| K010704 | Dornir Lc-1 CPAP System | Prym Medical, Ltd. | BZD | Class II | |
| K010676 | Simplicity Winged Qd Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K010531 | Ilt Deflecting Catheter, Model C114nd1 | Intra Luminal Therapeutics, Inc. | DQY | Class II | |
| K010383 | Temp Scan | Tenghi Co., Ltd. | FLL | Class II | |
| K010309 | Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator | Mutoh America Co., Ltd. | LFL | Unclassified | |
| K010174 | Tray Adapters, Multiple | Arplay Medical S.A. | IYE | Class II | |
| K010172 | Lead Blocks | Arplay Medical S.A. | IXI | Class II | |
| K010170 | Trident Porous Titanium Acetabular Component | Howmedica Osteonics Corp | LPH | Class II | |
| K010967 | Livesure Cocaine Screen Test | Pan Probe Biotech, Inc. | DIO | Class II | |
| K010740 | Fg-36Ux, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | ODG | Class II | |
| K010630 | Y-Tzp Powder and Procera Allzirkon | Procera Sandvik, Inc. | EIH | Class II | |
| K010195 | Premier Ultrasonic Scaler and Inserts | Premier Dental Products Co | ELC | Class II | |
| K010149 | Wujin #3 Femoral Nail | Biopro, Inc. | HSB | Class II | |
| K003561 | Invacare Passover Humidifier Model Isp9700 | Invacare GmbH | BTT | Class II | |
| K002929 | Dornier Compact Alpha Lithotripter | Dornier Medtech America, Inc. | LNS | Class II | |
| K002036 | Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod | Osi Medical, Inc. | DQA | Class II | |
| K010115 | Reflex Anterior Cervical Plate System | Howmedica Osteonics Corp | KWQ | Class II | |
| K011011 | Livesure Morphine Screen Test | Pan Probe Biotech, Inc. | DOE | Class II | |
| K010959 | Verdict -II Bar; Verdict -II Bzo | MEDTOX Diagnostics, Inc. | DIS | Class II | |
| K010956 | Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X | Boston Scientific Corporation | GEI | Class II | |
| K010814 | Emit 2000 Carbamazepine Assay, Model Osr4f229 | Syva Co., Dade Behring, Inc. | KLT | Class II | |
| K010812 | Emit 2000 Procainamide Assay, Model Osr4k229 | Syva Co., Dade Behring, Inc. | LAR | Class II | |
| K010781 | 3M Espe Haur | 3M Company | EBF | Class II | |
| K010778 | Niagara Slim-Cath | C.R. Bard Inc | MPB | Class II | |
| K010774 | Avl Hinge Knee System | Zimmer GmbH | KRO | Class II | |
| K010765 | Coulter Hmx Analyzer, Model 6605523, Coulter Hmx with Autoloader, Model 6605526 | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K010647 | Simplicity Infuser Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K010421 | Wiener Lab. Uricostat Enzimatico Aa, Models 2X50 Ml Catalogue No 1840106 and 4X50 Ml Catalogue No 1840105 | Wiener Laboratories Saic | KNK | Class I | |
| K010379 | Il Test Free Protein S | Instrumentation Laboratory Co. | GGP | Class II | |
| K010288 | Aneuvysion Muliticolor DNA Probe Kit | Vysis | OYU | Class II | |
| K003994 | Ksea Unidrive Ii/ii Plus and ENT Accessories | Karl Storz Endoscopy-America, Inc. | ERL | Class II | |
| K003842 | Prescott's Surgical Spear | Prescott's, Inc. | HOZ | Class II | |
| K003412 | Advia Centaur Rubella Igg Assay | Bayer Corp. | LFX | Class II | |
| K002131 | Lactosorb Ethmoid Stent | Biomet Microfixation | LYA | Class I | |
| K010942 | U04 | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K010926 | R-Si-Line Metal-Bite | R-Dental Dentalerzeugnisse GmbH | ELW | Class II | |
| K010846 | Simplicity Silver Set Soft Infusion | Sterling Medivations, Inc. | FPA | Class II | |
| K010758 | Heartwave Alternans Processing System, Aps | Cambridge Heart, Inc. | DPS | Class II | |
| K010756 | Ch 2000 Cardiac Diagnostic System | Cambridge Heart, Inc. | DQK | Class II | |
| K010742 | Moss Miami 5.5Mm Titanium Pin Nut | Depuyacromed | MNH | Class II | |
| K010684 | Rx Herculink Plus Biliary Stent System | Boston Scientific Corporation | FGE | Class II | |
| K010507 | Vistakon (Methafilcon a) Contact Lenses | Johnson & Johnson Vision Care, Inc. | LPL | Class II | |
| K010113 | Laser Mechanisms Laser Scanning System | Laser Mechanisms, Inc. | GEX | Class II | |
| K000592 | Unolok Plus Infusion Set and Vaku-8 Plus Blood Collection Set | Myco Medical Supplies Inc | FPA | Class II | |
| K010836 | At Work Drug Test, Model 9147T Awt | Phamatech Inc. | LAF | Class II | |
| K010833 | At Work Drug Test, Model 9177T Awt | Phamatech Inc. | DIO | Class II |