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 |
|---|---|---|---|---|---|
| K021887 | Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071 | Lin-Zhi International Inc | LDJ | Class II | |
| K021776 | Ksea Quadro Switch | Karl Storz Endoscopy-America, Inc. | OCX | Class II | |
| K021751 | Altaire Magnetic Resonance Imaging System | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K021747 | Degall Laparoscopic Gallbladder Extractor | Surgicon AG | GCI | Class II | |
| K021719 | Fortitude Cement Restrictor | Spinal Concepts, Inc. | JDK | Class II | |
| K021718 | Intraoral Imaging System, Model Suni-Ray | Suni Imaging Microsystems, Inc. | MUH | Class II | |
| K020537 | Tl10 Tensymeter Blood Pressure Monitoring System | Tensys Medical, Inc. | DXN | Class II | |
| K014270 | Minineph Human B2-Microglobulin Kit | The Binding Site | JZG | Class II | |
| K011327 | Db1 Embryo Freeze | Zander Medical Supplies, Inc. | MQG | Class II | |
| K022486 | K-Assay Hs-Crp Controls | Kamiya Biomedical Company, LLC | DCK | Class II | |
| K022435 | 507El Vital Signs Monitor | Criticare Systems, Inc. | DRT | Class II | |
| K022425 | Screwline | Altatec Biotechnologies N.A., Inc. | DZE | Class II | |
| K022414 | Stealthstation System Three Dimensional C-Arm Interface | Medtronic Navigation, Inc | HAW | Class II | |
| K022270 | Modification to Olympus Integrated Endosurgery System Endoalpha | Olympus Optical Co., Ltd. | ODA | Class II | |
| K022242 | Intervascular Intergard Knitted Vascular Graft Sizer | Intervascular, Inc. | DSY | Class II | |
| K022066 | Registrado X-Tra | Voco GmbH | ELW | Class II | |
| K022017 | Rhigene Mesacup-2 Test Rnp, Model M7741 | Rhigene, Inc. | LKO | Class II | |
| K021920 | 7.0 Fr. Endobronchial Blocker | Cook Inc. | CBI | Class II | |
| K021904 | Maeda Silver Acupuncture Needle | Maeda Toyokichi Shoten | MQX | Class II | |
| K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis US Corp. | FGE | Class II | |
| K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | FZP | Class II | |
| K021792 | Bilayer Matrix Wound Dressing | Integra LifeSciences Corporation | KGN | Unclassified | |
| K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders | Senorx, Inc. | KNW | Class II | |
| K021642 | Synthes Craniofacial Plates | Synthes (USA) Products LLC | JEY | Class II | |
| K021633 | Ecat Vision Pet Scanner, Models 3000 & 5000 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K020984 | Accessaed, Semi-Automatic External Defibrillators | Access Cardiosystems, Inc. | MKJ | Class III | |
| K020710 | Biotest Hemoglobin Measuring System | Biotest Medizintechnik GmbH | GKR | Class II | |
| K020597 | Serralgut | Serral, S.A. de C.V. | GAL | Class II | |
| K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | MHX | Class II | |
| K013618 | Intraoral Mandibular Distraction System | Osteomed | MQN | Class II | |
| K013038 | Safe Maxi Hollow Fiber Oxygenator, Model 016010 | Polystan A/S | DTZ | Class II | |
| K012678 | Reprocessed Sealed Electrophysiology Diagnostic Catheters | Sterilmed Inc | NLH | Class II | |
| K012523 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed Inc | NLH | Class II | |
| K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | IYN | Class II | |
| K022509 | Bruno Electra-Ride, Model Sre-2700 | Bruno Independent Living Aids, Inc. | ILK | Class II | |
| K022482 | Sensa-Cuff, Models Infant, Child, Adult | GE Medical Systems Information Technologies, Inc. | DXQ | Class II | |
| K022395 | 1.5T Scanmed Pv Array | Medic, Inc. | MOS | Class II | |
| K022372 | Hrh-127-8 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K022354 | Ultraguide Ctg 2000Sa | Ultraguide, Ltd. | JAK | Class II | |
| K022337 | 3D Navigation Interface for Siremobile ISO-C 3D | Siemens Medical Solutions USA, Inc. | IZL | Class II | |
| K022328 | Ems Piezon Master 600 | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K022285 | Modification to Isola Spinal System | Depuyacromed | MNI | Class II | |
| K022197 | Surface Electrode for Electroencephalography | The Electrode Store | GXY | Class II | |
| K022074 | Spherz | I.Z.I. Corp. | HAW | Class II | |
| K021999 | Gripper Plus Needle | Abbott Medical | FPA | Class II | |
| K021956 | Mhs Med Light 1000 | Micro Health Systems, Inc. | ILY | Class II | |
| K021631 | Isa-21 Interventional Spine Array Coil | Mri Devices Corp. | MOS | Class II | |
| K021599 | 96 Channel EEG Headbox Model Emu96 | Excel Tech., Ltd. | GWQ | Class II | |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option | Medtronic, Inc. | CBK | Class II | |
| K020759 | 7600 Series Reusable Full-Face Cpap/nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit | Hans Rudolph, Inc. | BZD | Class II |