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 |
|---|---|---|---|---|---|
| K042910 | Venture Wire Control Catheter, Model Wcc | Velocimed, Inc. | DQY | Class II | |
| K042848 | Frc Postec Plus | Ivoclar Vivadent, Inc. | ELR | Class I | |
| K042812 | Bblchromagar Mrsa | Becton Dickinson & Co | JSO | Class II | |
| K042746 | Pet-Dose | Comecer S.r.l. | KPT | Class II | |
| K042662 | Nio 5Mp Medical Flat Panel Display System | Barco NV Barcoview | LLZ | Class II | |
| K042614 | S&c-Self Etch Pr-Bond | S & C Polymer GmbH | KLE | Class II | |
| K042491 | Bd Onecath Peripherally Inserted Central Catheter | Becton Dickinson & Co | LJS | Class II | |
| K042314 | Syringe Grip for the Avonex Pre-Filled Syringe | Biogen | FMF | Class II | |
| K042152 | Binding Site Igg Sublcass Olympus Kits | The Binding Site | CFN | Class II | |
| K041470 | Morton Iui Catheters | Fertility Technology Resources, Inc. | MQF | Class II | |
| K041284 | Medicult Ivm System | Medicult A/S | MQL | Class II | |
| K041242 | Candela Smoothbeam Laser System | Candela Corporation | GEX | Class II | |
| K040708 | Status First Strep a | Princeton BioMeditech Corp. | GTY | Class I | |
| K033033 | Vizilite-Blue Oral Exam Kit | Trylon Corp. | EAZ | Class I | |
| K031402 | Perfecta Femoral Stem | Wrightmedicaltechnologyinc | LPH | Class II | |
| K043097 | 3Viseon | 3Mensio Medical Imaging BV | LLZ | Class II | |
| K043025 | Synerad Omni, Digital X-Ray System, Model An6250 | Analogic Corp. | KPR | Class II | |
| K042966 | Duet Suture Anchor, Models Bxs4216, Bxs4216h; Impact Suture Anchor, Models Bxs4218, Bxs4218h | Linvatec Biomaterials, Ltd. | MAI | Class II | |
| K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek | KWQ | Class II | |
| K042906 | Amplife Digital Infrared Ear Thermometer, Model E101 | Amplife Corporation | FLL | Class II | |
| K042897 | Autobahn Tissue Closure Device and Disposable Cartridge | Ethicon Endo-Surgery Inc | GAL | Class II | |
| K042894 | Imalux Niris Imaging System | Imalux Corporation | NQQ | Class II | |
| K042731 | Architect Ca 125 II Assay | Fujirebio Diagnostics, Inc. | LTK | Class II | |
| K042697 | Second Look Viewer | Icad, Inc. | LLZ | Class II | |
| K042680 | Rhigene Hep-Ana Test System | Corgenix, Inc. | DHN | Class II | |
| K042671 | Planmed Sophie Nuance Classic | Planmed Oy | IZH | Class II | |
| K042661 | Nio 3Mp Medical Flat Panel Display System | Barco NV Barcoview | LLZ | Class II | |
| K042660 | Nio 2Mp Medical Flat Panel Display System | Barco NV Barcoview | LLZ | Class II | |
| K042601 | Capnostat 5 | Respironics Novametrix, LLC. | CCK | Class II | |
| K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein | Ortho-Clinical Diagnostics, Inc. | DDG | Class II | |
| K042473 | Cobe Angel Whole Blood Separation System | LivaNova USA, Inc. | JQC | Class I | |
| K042390 | Etest for Gemifloxacin | Ab Biodisk | JWY | Class II | |
| K042347 | Modification to Dimension Nt-Probnp Flex Reagent Cartridge Method | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K042227 | Instant-View Troponin I Test | Alfa Scientific Designs, Inc. | MMI | Class II | |
| K042127 | Smith & Nephew Modular Hip | Smith & Nephew, Inc. | MEH | Class II | |
| K041817 | West Nile Detect Igm Elisa | Inbios Intl., Inc. | NOP | Class II | |
| K043111 | Plaqueview Software, Model Cspv-0001A | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | NHA | Class II | |
| K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal S.A. | IZL | Class II | |
| K042886 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K042881 | Pmd-2000 Interferential Stimulator | Phoenix Medical Devices, LLC | IPF | Class II | |
| K042876 | Urs Lp Digital, Millennium, Radpro | Sedecal S.A. | KPR | Class II | |
| K042786 | Best Model # 81-01 Series Ir-192 Sources | Best Medical International, Inc. | KXK | Class II | |
| K042694 | Advanced Lung Analysis II | GE Healthcare | OEB | Class II | |
| K042685 | Metricath System | Angiometrx, Inc. | DQO | Class II | |
| K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and II | Ortho-Clinical Diagnostics, Inc. | DCF | Class II | |
| K042625 | Quikread Crp Calibrator Set | Orion Diagnostica, Inc. | JJY | Class I | |
| K042521 | Vitros Chemistry Products Apoa1 and Apob Reagents, Calibrator Kits 21 and 22 and Apoa1 and Apob Performance Verifiers | Ortho-Clinical Diagnostics, Inc. | JIT | Class II | |
| K042365 | Synthes (USA) Neuro Plate and Screw System | Synthes (USA) Products LLC | JEY | Class II | |
| K042348 | Gradia Direct Loflo | GC America Inc. | EBF | Class II |