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 |
|---|---|---|---|---|---|
| K070900 | Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer Kit | The Binding Site | DFH | Class II | |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039 | Vygon Corp. | FOZ | Class II | |
| K070015 | Cobalt V Radiopaque Vertebroplasty Bone Cement | Biomet Manufacturing Corp | LOD | Class II | |
| K073323 | Sa-3000P | Medicore Co. Ltd. | JOM | Class II | |
| K073203 | Carescape V100 | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision Inc. | MVN | Class II | |
| K072982 | Pari Hydrate V | Pari Innovative Manufacturers, Inc. | BTT | Class II | |
| K072843 | Yg-125T and Yg-135T Nasal Adapter | Nihon Kohden America Inc | CCK | Class II | |
| K072520 | Tephaflex Surgical Film | Tepha, Inc. | FTL | Class II | |
| K072482 | Hypodermic Needle-Pro Safety Allergy Tray | Abbott Medical | MEG | Class II | |
| K072463 | Satyrne Interflex Mandibular Fixation System | Satyrne Medical | JEY | Class II | |
| K072449 | Cp100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn Inc | DPS | Class II | |
| K072446 | Mobil-O-Graph Ng 24 H Abp-Control | I.E.M. GmbH | DXN | Class II | |
| K072383 | Habib Endoblate | Emcision, Ltd. | KNS | Class II | |
| K072346 | Pm-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K072194 | Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25 | Renu Medical, Inc. | NLF | Class II | |
| K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics | Bmeye B.V. | DXN | Class II | |
| K071385 | Sterrad 100Nx Sterilizer | Advanced Sterilization Products | MLR | Class II | |
| K073182 | Gyn Disposables Tenaculum 356T | Gyn-Disposables, Inc. | HDC | Class II | |
| K072922 | 3S Hemi Toe | Trilliant Surgical LLC | KWD | Class II | |
| K072672 | Sequoia Spinal System, Model 3300 Series | Spinal Concepts, Inc. | NKB | Class II | |
| K072650 | Ist Anterior Cervical Plate System | Innovative Spinal Technologies, Inc. | KWQ | Class II | |
| K072578 | Synthes (USA) Epoca Shoulder Prosthesis System | Synthes (USA) Products LLC | HSD | Class II | |
| K071815 | Noveon, Model Ls1100-01-0968 | Nomir Medical Technologies, Inc. | GEX | Class II | |
| K063245 | Elutia Coated Closed Surgical Wound Drain | Xtant Medical Holdings, Inc. | OEI | Class II | |
| K062931 | Implus Implant System | Leader Italia S.r.l. | DZE | Class II | |
| K073102 | Biolox Delta Ceramic Heads with 100Kgy E-Poly Acetabular Liners | Biomet Manufacturing Corp | LZO | Class II | |
| K073054 | Modification to Aperfix Femoral Implant with Inserter | Cayenne Medical Inc. | HWC | Class II | |
| K072795 | Models Ems 5.0, Ems 5.1 | Koalaty Products, Inc. | IPF | Class II | |
| K072260 | Nuface, Model Nu-4003 | Carol Cole Company | NFO | Class II | |
| K071624 | Everelife Transcutaneous Muscle Stimulator | Everlife Medical Equipment Co., Ltd. | GZJ | Class II | |
| K072921 | Disposable Infusion Pump Kit, Go Pump Rapid Recovery System | Symbios Medical Products, LLC | MEB | Class II | |
| K072846 | Csf Automated Control, Models Csf001, Csf003 | R & D Systems, Inc. | JPK | Class II | |
| K072827 | Rpmi 1640 Agar W/mops and 2% Glucose | Remel Inc | MJE | Class II | |
| K072822 | Funhaler, Model V-201E | Infamed, Ltd. | CAF | Class II | |
| K072780 | Model R302dacs/a Automatic X-Ray Collimator | Ralco S.r.l. | IZW | Class II | |
| K072509 | Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing Tray | Medcomp | LJS | Class II | |
| K071588 | Dispenser Dp 20 | Nouvag AG | FRN | Class II | |
| K070513 | Hamilton-G5 | Hamilton Medical AG | CBK | Class II | |
| K062658 | Primus A1care Assay | Trinity Biotech (Primus Corporation dba Trinity Biotech) | LCP | Class II | |
| K062575 | Modification to: Accusign Rc Doa 10 (Met/opi/coc/thc/pcp/bzo/bar/mtd/tca/amp | Princeton BioMeditech Corp. | LAG | Class II | |
| K073181 | Neocoil 1.5T 16 Channel Cardiac-Abdominal-Pelvic Array Coil | NeoCoil, LLC | MOS | Class II | |
| K073146 | Padnet+ | Biomedix Wai | JOM | Class II | |
| K073140 | Vitalogik Model 4000/4500 | Mennen Medical, Inc. | DSI | Class II | |
| K073122 | Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle | Covidien Lp, Formerly Registered AS Tyco Healthcar | FMI | Class II | |
| K073108 | Zeno Zr Disc | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K073081 | Jet Software for Excelart Vantage Atlas-Z and Atlas-X | Toshiba America Medical Systems, In.C | LNH | Class II | |
| K073013 | Ctu676 Device | Compression Technologies Unlimited, Inc. | JOW | Class II | |
| K072867 | Imix 2000 Digital Radiography System, Models Unv 3K, Unv 3Kw, Unv 4K | Imix Adr Finland Oy | KPR | Class II | |
| K072850 | MRI System, Model Magfinder II / Ai 3200 | Advanced Imaging Laboratory | LNH | Class II |