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 |
|---|---|---|---|---|---|
| K082141 | Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 | Biokit, S.A. | JIT | Class II | |
| K082042 | Gongdong Disposable Sharp Container | Zhejiang Gongdong Medical Plastic Factory | MMK | Class II | |
| K081907 | Non-Sterile, Powder Free Latex Examination Gloves with Polymer Coating and Protein Claim (50 Micrograms or Less) | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K081758 | Healos Fx Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015 | DePuy Spine, Inc. | MQV | Class II | |
| K081588 | Re-Zorb Plating System | Acute Innovations, LLC | HRS | Class II | |
| K081042 | Microthermx-100 Microwave Ablation System and Accessories | Bsd Medical Systems Corp. | NEY | Class II | |
| K080795 | Ultra Surgical Gown & Fluid Barrier Surgical Gown | Kimberly-Clark Corporation | FYA | Class II | |
| K080594 | Ms System (Narrow Ridge) | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K080473 | Embryoassist and Embryoassist with Phenol Red | Medicult A/S | MQL | Class II | |
| K080094 | Olympus Total Bhcg Test Systen | Olympus Life Science Research Europa GmbH (Europa) | DHA | Class II | |
| K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | Sybron Dental Specialties, Inc. | EFB | Class I | |
| K073317 | Starlight, Model Pd9012 | F.P. Rubinstein Y Cia S.r.l. | GEX | Class II | |
| K082374 | Vivid I and Vivid Q | GE Medical Systems Israel, Ultrasound, Ltd. | IYN | Class II | |
| K082104 | Ge Lightspeed Rt16 / Lightspeed Xtra V2 CT System (Aka Ge Lightspeed Rt16 / Lightspeed Xtra CT System | GE Healthcare | JAK | Class II | |
| K082077 | Bt3/6, Bt12 | Corscience GmbH & Co. KG | DXH | Class II | |
| K082022 | Optetrak 9Mm Cruciate Retaining Tibial Insert, Slope ++ | Exactech, Inc. | JWH | Class II | |
| K081925 | Snapshot | Palodex Group Oy | MUH | Class II | |
| K081821 | D.a.r.t. Pro Kit (D.a.r.t. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | MMK | Class II | |
| K081575 | Hu/hs/hg Prosthetic System | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K081568 | Antegra-T | Synthes Spine Co.Lp | KWQ | Class II | |
| K081116 | G-Ivf G5 Series | Vitrolife Sweden AB | MQL | Class II | |
| K080711 | 1.10-Year Fracture Risk Questionnaire Option for Qdr X-Ray Bone Densitometer, Model Qdr Option | Hologic, Inc. | KGI | Class II | |
| K080420 | Resert Xl Hld High Level Disinfectant | STERIS Corporation | MED | Class II | |
| K080375 | Rmx Physiological Data Recorder | S.L.P., Ltd. | MNR | Class II | |
| K082373 | Noras Mr-Bi320-Pa 3T | NORAS MRI products GmbH | MOS | Class II | |
| K082341 | Dsa 2000Ex | Eigen | LLZ | Class II | |
| K082239 | Depuy C-Stem Amt | Depuy Orthopaedics Inc. | JDI | Class II | |
| K082186 | Modification to Pathway Pv Atherectomy System | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K082122 | Mlci2 | Elekta Limited | IYE | Class II | |
| K081937 | Picosat II and M3002a Multimeasurement and M1020b Plug-in Modules Spo2 Pulse Oximetry Module | Philips Medizin Systeme Boeblingen GmbH | DQA | Class II | |
| K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | HWC | Class II | |
| K081891 | Fukuda Denshi Dynascope Model Ds-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | MHX | Class II | |
| K081887 | Lute-It II Veneer Cement, Model No6 | Pentron Clinical Technologies | EMA | Class II | |
| K081844 | Ge Datex-Ohmeda Avance | GE Healthcare | BSZ | Class II | |
| K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/mbi Calibrator, Models Df38, Df32 | Siemens Healthcare Diagnostics Inc. | CGS | Class II | |
| K081699 | Planmeca Sovereign | Planmeca U.S.A. Inc | EIA | Class I | |
| K081622 | Universal Clamp Stainless Steel System | Spinal Concepts, Inc. | JDQ | Class II | |
| K081610 | Sysmex Model Xs-1000Ic Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K081432 | Healos II Bone Graft Substitute | DePuy Spine, Inc. | LYC | Class II | |
| K081141 | Combocare 2000 | Xanacare Technologies, LLC | GZJ | Class II | |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200A | Nihon Kohden America Inc | OLT | Class II | |
| K080529 | Stereos Workstation | Biospace Med | LLZ | Class II | |
| K073685 | Ota Collagen Biomaterial | Osseous Technologies of America | NPL | Class II | |
| K072213 | Perimetrics Periometer | Perimetrics, Inc | EKX | Class I | |
| K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | DYB | Class II | |
| K082323 | Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K082306 | Powerloc Clear Safety Infusion Set | C.R. Bard Inc | FPA | Class II | |
| K082194 | Laurimed Percutaneous Discectomy System, Model Fg-000002 | Laurimed, LLC | HRX | Class II | |
| K082132 | Bausch & Lomb D4600a Air Exchange Line Pack | Bausch & Lomb Incorporated | HQC | Class II | |
| K081849 | Blackstone Pillar Sa Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | OVD | Class II |