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 |
|---|---|---|---|---|---|
| K083763 | Zeus CT Picc 4 Fr and 5 Fr Single and Dual Lumen | R4 Vascular, Inc. | LJS | Class II | |
| K083615 | Euroimmun Anti Bp 180-4X Elisa (Igg) | Euroimmun US Inc. | OEG | Class II | |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164 | Serim Research Corp. | JOJ | Class II | |
| K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | LON | Class II | |
| K081845 | Ivent101 | Versamed Medical Systems, Inc. | CBK | Class II | |
| K081830 | Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid Qc1 | Phadia AB | DHB | Class II | |
| K081709 | Olympus Afp - Alpha-Fetoprotein | Olympus Life Science Research Europa GmbH (Europa) | LOJ | Class II | |
| K090610 | Hospira Vital Signs Wireless Monitoring System | Abbott Medical | DRG | Class II | |
| K090380 | Magnum M Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K090229 | Diagnostic Doppler Ultrasound System 2-5Mhz Curved Linear Array, 5-10Mhz Linear Array, 2-4Mhz Phase Array, 4-8Mhz Transv | Chang Gung Medical Supplies & Equipment Corp. | IYN | Class II | |
| K090214 | Verathon Inc. Bladderscan Bvm 9500 Ultrasound | Verathon Incorporated | IYO | Class II | |
| K090095 | Lungpoint Virtual Bronchoscopic Navigation Vbn System | Broncus Technologies, Inc. | LLZ | Class II | |
| K090020 | Bel-Cypher, Model Y977 | Takara Belmont Corporation | MUH | Class II | |
| K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.r.l. | DQY | Class II | |
| K083651 | Revelation Stem, Model 427-21/42-080/180 | Encore Medical, LP | KWA | Class III | |
| K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | CBK | Class II | |
| K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls | Instrumentation Laboratory Co. | JPA | Class II | |
| K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K083316 | 3D Oct-1000 Mark II Optical Coherence Tomography System | Topcon Healthcare, Inc. | OBO | Class II | |
| K083263 | Symcare Diabetes Management Program | Symcare Personalized Health Solutions, Inc. | NBW | Class II | |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596 | Phadia AB | LJM | Class II | |
| K083142 | Picasso Laser System | Cao Group, Inc. | GEX | Class II | |
| K083073 | Theken Atoll Cervico-Thoracic System | Theken Companies LLC | MNI | Class II | |
| K082735 | Stone Grasping Basket, Model Pd-T1 2115 | Sialo Technology, Ltd. | GCJ | Class II | |
| K082345 | Oxygen Demand Valve | BPR Medical Limited | CBP | Class II | |
| K080404 | Easyqc - Chemistry with Electrolytes; Chemistry; Electrolytes Kit; Chemistry Calibrator, Crea-U Claibrator | Medica Corp. | JIX | Class II | |
| K090168 | Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415 | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K083388 | Synthes Matrixorthognathis Fixation System | Synthes (USA) Products LLC | JEY | Class II | |
| K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | HPZ | Class II | |
| K083062 | Root Canal Xr | S & C Polymer GmbH | KIF | Class II | |
| K081953 | Supercath 5 | Togo Medikit Co., Ltd. | FOZ | Class II | |
| K081813 | Universal Compression Fracture Repair System | US Implant Solutions, LLC | HWC | Class II | |
| K081740 | Hemoband, Models Hb-Ns and Hb-Nsxl | Innovations for Access, Inc. | KOC | Class II | |
| K090374 | Sterile Dvr Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5Mm Threaded and Smooth Pegs, Model(s | Depuy Orthopaedics Inc. | LXT | Class II | |
| K090325 | Jetstream G2 System, Models Pv20300 (Jetstream G2 Catheter and Control Pod); Pvcn100 (Pv Console) | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K090313 | Pigalileo Tkr Base V2.3 and Cas V4.1 | Smith & Nephew, Inc. | OLO | Class II | |
| K090279 | Sedecal, Millennium Plus | Sedecal S.A. | KPR | Class II | |
| K090124 | Gryphon P Br Ds Anchor W/orthocord,gryphon P Br Anchor W/orthocord, Model 210813,210814 | DePuy Mitek, Inc. | MAI | Class II | |
| K090100 | Softseal-Stf | Chitogen Inc | QSY | Unclassified | |
| K083906 | Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/n 04851534, P/n 10376487 | Siemens Healthcare Diagnostics Inc. | NDY | Class II | |
| K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | LZO | Class II | |
| K083738 | Hi-Torque Flex-T Guide Wire, Models 1012067-01, 02, 03, 04 and 05 | Abbott Vascular | DQX | Class II | |
| K083726 | Pedinail Intramedullary Nailing System | Orthopediatrics Corp | HSB | Class II | |
| K083625 | Aero Dv Tracheobronchial Stent System | Alveolus, Inc. | JCT | Class II | |
| K083570 | U-Right Td-4249/U-Right Td-4250 Blood Glucose Monitoring System | Taidoc Technology Corporation | CGA | Class II | |
| K083314 | Immulite 2000 3Gallergy Specific Ige Assay Kit | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori Ng System, Model S1 | Cadi Scientific Pte.Ltd | FLL | Class II | |
| K082937 | Lifepak 15 Monitor/defibrillator | Physio Control, Inc. | MKJ | Class III | |
| K082190 | Baxolve Xp Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 | Bio-Medical Research, Ltd. | GZJ | Class II | |
| K081970 | Bioclean Chemo Shield | Nitritex (M) Sdn. Bhd. | LZA | Class I |