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 |
|---|---|---|---|---|---|
| K063197 | 21.3 Inch (54Cm) Monochrome Lcd Monitor Mdl2118a (Me355i2) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K063188 | Del-Ims | Del Medical Imaging Corp. | LLZ | Class II | |
| K063177 | Rapid Strand Rx | Oncura, Inc. | KXK | Class II | |
| K062833 | Powered Ez-Io Bone Marrow Aspiration System | Teleflex Medical | FCF | Class II | |
| K062748 | Modification: to Depuy Delta Ceramic Femoral Head | Depuy Orthopaedics Inc. | LZO | Class II | |
| K062688 | Powder-Free Black Latex Examination Glove with Protein Labeling Claim | UG Healthcare (USA), Inc. | LYY | Class I | |
| K062589 | Serenity Psf (Pneumatic Skin Flattening) System | Inolase 2002, Ltd. | GEX | Class II | |
| K062340 | Cardiooptics Augmentative Cardiac Optical Imaging System | Cardio-Optics, Inc. | LYK | Class II | |
| K062313 | Senstouch High Risk Latex Examination Gloves, Powder Free, Non Sterile | Pt Mahakarya Inti Buana | LYY | Class I | |
| K062271 | M3290a Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) | Philips North America LLC | MHX | Class II | |
| K061814 | Vasopress Dvt System, Model Vp500d | Compression Therapy Concepts, Inc. | JOW | Class II | |
| K052519 | Spectral West Nile Virus Igm Status Test | Spectral Diagnostics, Inc. | NOP | Class II | |
| K063305 | Stimulating Bur Guard | Medtronic Xomed, Inc. | ETN | Class II | |
| K063279 | Novation Splined Rdd Femoral Stems | Exactech, Inc. | LZO | Class II | |
| K063195 | Ligasure Advance Laparoscopic Sealer/divider with Dissecting Electrode, Models Lf5034 and Lf5044 | Medtronic, Inc. | GEI | Class II | |
| K063141 | Omniguide Zero Flow Zf-T 150 Waveguide Fiber | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K063060 | Blueshine Light Shine Systems, Sp, Twin and Compact Sp | Blueshine SRL | GEX | Class II | |
| K062749 | Sbf 15 Esthetic Abutment 1Mm Np, Model 33699, Sfb 15 Esthetic Abutment 1Mm Rp, Model 33701, Cfb 15 Esthetic Abutment 2Mm | Nobel Biocare AB | NHA | Class II | |
| K062702 | Ulticare Disposable Syringes and Needles | Ultimed, Inc. | FMF | Class II | |
| K062592 | Cadd-Sentry Pro Medication Safety Software | Abbott Medical | FRN | Class II | |
| K062581 | Olympus Tsh Reagent, Calibrator and Control and Au3000i Immunoassay System | OLYMPUS Corporation of the Americas | JLW | Class II | |
| K062466 | Arthrex Interference Screw | Arthrex GmbH | MAI | Class II | |
| K063435 | Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K063344 | Caas Qca 3D | PIE Medical Imaging B.V. | LLZ | Class II | |
| K063288 | Signature Edition Gold Infusion System, Model 7X3x | Cardinal Health 303,Inc. | FRN | Class II | |
| K063010 | Regen Biocement | Steiner Laboratories | LYC | Class II | |
| K063003 | Aurora | Parkell, Inc. | EBZ | Class II | |
| K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | EFB | Class I | |
| K062579 | Omnipicc P.i. | Boston Scientific Corporation | LJS | Class II | |
| K063299 | Microscan Microstrep Plus Panel-Clarithromycin | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K063146 | Accu-Chek Linkassist | Disetronic Medical Systems | KZH | Class II | |
| K062828 | Mouthguard and Aligner Materials | Dentsply Intl. | MQC | Unclassified | |
| K062300 | Ox-Sox, Model C, D, E, | Pattient Safety Innovations, LLP | ECX | Class I | |
| K063421 | Dx-Si | Agfa Corp. | MQB | Class II | |
| K063330 | Orthocon Hemasorb Resorbable Hemostatic Bone Putty | Orthocon, Inc. | MTJ | Unclassified | |
| K063327 | Orthoview | Merdian Technique, Ltd. | LLZ | Class II | |
| K063303 | Universal Locking System, 2.7Mm Plates & Screws | Zimmer GmbH | HRS | Class II | |
| K063273 | Panalok Quickanchor Plus, Panalok Rc Quickanchor Plus Dual Suture, Panalok Anchor | Depuy Miltek, A Johnson & Johnson Co. | JDR | Class II | |
| K063257 | Fmp Coated Spiked Acetabular Cup; Hemispherical Acetabular Cup; Flared Rim Acetabular Cup; Metal/metal Acetabular Insert | Encore Medical, LP | LPH | Class II | |
| K063247 | Xplorer 1800 Digital Radiographic System with Universal Stand | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K063246 | Xplorer 1500 Digital Radiographic System with Stand | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K063212 | Clever Chek Td-4231 and Td-4223 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K063156 | Modification to Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K063021 | Profiler 2 | Sun Nuclear Corporation | IYE | Class II | |
| K062985 | Ivus Enhancer | Indec Systems, Inc. | LLZ | Class II | |
| K062980 | Activascrew | Bioretec Ltd. | HWC | Class II | |
| K062857 | Kls Martin Quick Disc | KLS-Martin L.P. | GXN | Class II | |
| K062855 | Calcium | Abbott Medical | CJY | Class II | |
| K062817 | Ptw David Imrt Qc Verification System | Ptw-New York Corp. | IYE | Class II |