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 |
|---|---|---|---|---|---|
| K081983 | M3290a Intellivue Information Center Software, Release 1.00 | Philips North America LLC | MHX | Class II | |
| K081722 | Ysio | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K081600 | Steris Resert Xl Test Strip | STERIS Corporation | JOJ | Class II | |
| K081075 | Painshield Md | Nano Vibronix, Ltd. | PFW | Class II | |
| K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corporation | OTP | Class III | |
| K080643 | Elecsys Anti-Tshr Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K073334 | Ohmniscan Ng | Christine Valmy, Inc. | MNW | Class II | |
| K072950 | Cygnus 12 Lead ECG Module | Cygnus, LLC | KRE | Class II | |
| K082244 | Pca-8000A, Mark 11, Pet / CT System | Toshiba America Medical Systems, In.C | KPS | Class II | |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products Dt Calibrator Kit, Models Ci-Dt Slides:131 4905 | Ortho-Clinical Diagnostics, Inc. | CGZ | Class II | |
| K081899 | Anyray Portable X-Ray System | E-Woo Technology | EHD | Class II | |
| K081847 | Picasso Master, Ect and Master 3D | E-Woo Technology | JAK | Class II | |
| K081566 | Smith & Nephew Oxinium Dh Femoral Heads | Smith & Nephew, Inc. | LPH | Class II | |
| K081405 | Xeracem | Doxa Dental AB | EMA | Class II | |
| K081393 | Orthodontic Temporary Anchorage Implant Screw | G & H Wire Company | OAT | Class II | |
| K081388 | Glucocare Intensive Glycemic Control System | Pronia Medical System, LLC | NDC | Class II | |
| K081896 | Biogenics Bioquad 4-Well Ivf Culture Dish | Biogenics, Inc. | MQK | Class II | |
| K081875 | Gentian Cystatin C Immunoassay | Gentian AS | NDY | Class II | |
| K081679 | Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05 | Encore Medical, LP | LPH | Class II | |
| K081657 | Powdered Vinyl Patient Examination Gloves, (Light Yellow) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | |
| K080510 | Vip Pulmonary Function System | Viasys Healthcare GmbH | BTY | Class II | |
| K080259 | Jmea Cannulated Bone Screw System | Jmea Corporation | HWC | Class II | |
| K080102 | Tq Solo and Solo Pro and Ls50 Accessory and Mr4 Multi Radiance Therapy System | Escada International, Inc. | ILY | Class II | |
| K073427 | Medilas D Family Lasers | Dornier Medtech America, Inc. | GEX | Class II | |
| K082288 | Haida Hd21 | Jiangyin East China Medical Technology Co., Ltd. | ITI | Class II | |
| K082274 | Haida Model Hd11 Manual Wheelchair | Jiangyin East China Medical Technology Co., Ltd. | IOR | Class I | |
| K082191 | Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080 | Cardiomems, Inc. | NQH | Class II | |
| K082061 | Inquiry H-Curve Tv Steerable Diagnostic Catheter | Irvine Biomedical. Inc. | DRF | Class II | |
| K081549 | Rx Accunet Lp Embolic Protection System | Abbott Medical | NTE | Class II | |
| K081465 | Axium Detachable Coil System | Medtronic, Inc. | KRD | Class II | |
| K080872 | Amedicheck Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma,bar, Bz | Amedica Biotech, Inc. | LDJ | Class II | |
| K080641 | Trueresult Blood Glucose System E4h01-81 | Home Diagnostics, Inc. | NBW | Class II | |
| K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | OCW | Class II | |
| K081586 | Reprocessed External Fixation Device | Sterilmed Inc | KTT | Class II | |
| K073579 | Dynamesh-Pp Standard, Model Pp02nnnn, Dynamesh-Pp Light, Model Pp01nnnn | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | FTL | Class II | |
| K073444 | Triton Meidcal Tmed IV-Set | Triton Medical, LLC | FPA | Class II | |
| K072974 | Surgimesh Xb | Aspide Medical | FTL | Class II | |
| K072708 | Absolute Pro .035 Self-Expanding Stent System | Abbott Vascular-Vascular Solutions | FGE | Class II | |
| K082185 | Ge Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 | GE Medical Systems Ultrasound and Primary Care Dia | IYO | Class II | |
| K082182 | Ap 34 Multi-Therapy Infusion Pump | Q-Core, Ltd. | FRN | Class II | |
| K082075 | Hansen Medical Dilator for Artisan Control Catheter | Hansen Medical, Inc. | DRE | Class II | |
| K082034 | Modification to Merci Retriever | Concentric Medical, Inc. | NRY | Class II | |
| K081951 | Aneroid Sphygmomanometer, Model Kt-A01 | Wenzhou Kindcare Import & Export Co., Ltd. | DXQ | Class II | |
| K081757 | Verista Imaging Isocam II Gamma Camera | Verista Imaging, Inc. | IYX | Class I | |
| K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | LLZ | Class II | |
| K081365 | Sjm Confirm Model Dm2100 Implantable Cardiac Monitor and Model Dm2100a Patient Activator | Abbott Medical | MXC | Class II | |
| K081302 | Rescue External Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | KWQ | Class II | |
| K080685 | Hiploc Compression Hip Screw | Biomet Manufacturing Corp | JDO | Class II | |
| K080530 | Modification to Cutera Er:ysgg Laser Handpiece | Cutera Inc | GEX | Class II |