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 |
|---|---|---|---|---|---|
| K010184 | Chess Hand Surgery System | Canica Design, Inc. | MDM | Class I | |
| K003877 | Mar Cor Services Semper Pure Ro Machine | Mar Cor Services, Inc. | FIP | Class II | |
| K002427 | Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026 | Diversatek Healthcare Inc | FFX | Class II | |
| K011616 | Induo Blood Glucose Meter | Inverness Medical Innovations, Inc. | NBW | Class II | |
| K011593 | Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves, Color Blue Non-Sterile | Ansell Healthcare Products LLC | LZA | Class I | |
| K011576 | Medcomp Ash Split | Medical Components, Inc. | NFK | Class II | |
| K011389 | Hemoglobin F & A2 Control (Beta-Thalassaemia Control) | Canterbury Health Laboratories | JCM | Class II | |
| K010874 | 6F Mach 1, Model 34356-Xxx | Boston Scientific Corporation | DQY | Class II | |
| K010838 | Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 Mm, Models A14003, A14004, A14005, A14006, A14007, A14008 | Jomed AG | DQY | Class II | |
| K010026 | Embogold Microsphere | Biosphere Medical, S.A. | HCG | Class II | |
| K002885 | Dade Pfa-100 Platelet Function Analyzer Model-100, Dade Pfa Collegen/epinephrine Test Cartride, Dade Pfa Colleagen /Adp | Siemens Healthcare Diagnostics Inc. | JOZ | Class II | |
| K011738 | Accu-Chek Active System | Roche Diagnostics GmbH | NBW | Class II | |
| K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 | Medtronic, Inc. | MJN | Class II | |
| K011486 | Q-Rad Radiographic System | Quantum Medical Imaging, LLC | KPR | Class II | |
| K011297 | Nipro Safetouch Scalp Vein and Blood Collection Set | Nipro Medical Corporation | FOZ | Class II | |
| K011292 | Ziehm Vision | Ziehm International, Inc. | OWB | Class II | |
| K011284 | Thin Film Dressing for Ultrasound Exam | Martin E. Wendelken | ITX | Class II | |
| K011150 | Dridau Opiate Assay | Microgenics Corporation | DJG | Class II | |
| K010940 | Sealapex 4 | Sybron Dental Specialties, Inc. | KIF | Class II | |
| K010916 | Ptw Dosimetry Diode, T60008 | Ptw-New York Corp. | IYE | Class II | |
| K010884 | Titanium Compression Anchor System | Anchor Medical Technologies | HWC | Class II | |
| K010876 | Nti Tension Suppression System | Nti-Tss, Inc. | OCO | Unclassified | |
| K010456 | Bioscanner Creatinine Test Strips | Polymer Technology Systems | JFY | Class II | |
| K010410 | Jms Apheresis Needle Wing Eater, Model 14G-18G | JMS Co., Ltd. | FOZ | Class II | |
| K010406 | Jms A.v. Fistula Needle Set Wing Eater, Model 14G-18G | JMS Co., Ltd. | FOZ | Class II | |
| K011858 | Interlink Threaded Lock Cannula | BD | FPA | Class II | |
| K011819 | Radial Head Implant | Avanta Orthopaedics, Inc. | KWI | Class II | |
| K011634 | Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000 | ArthroCare Corporation | GEI | Class II | |
| K011577 | Ocu-Flex 55 Spherical, Toric,thin Zone Toric,aspherical,toric Aspherical and Thin Zone Toric Aspherical (Methafilcon a)s | Ocu-Ease Optical Products, Inc. | LPL | Class II | |
| K011567 | Tornier Total Elbow Prosthesis | TORNIER Inc. | JDB | Class II | |
| K011187 | Simplicity Soft Yp Infusion Set for Use with the Minimed Paragigm Infusion Pumps | Sterling Medivations, Inc. | FPA | Class II | |
| K011172 | Arthrex Bio-Transfix | Arthrex GmbH | MNU | Class II | |
| K011137 | Resorbable Hammertoe Pin | Zimmer GmbH | JDW | Class II | |
| K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | |
| K010987 | Ksea Miniature Telescope and Accessories | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K010928 | Prolite Vl Pulsed Light System | Medical Bio Care Sweden AB | GEX | Class II | |
| K010927 | Modification to Prolite Pulsed Light System | Medical Bio Care Sweden AB | GEX | Class II | |
| K010902 | Medpor Quad Motility Implant | Porex Surgical, Inc. | HPZ | Class II | |
| K010901 | Fixion Intramedullary Nailing System (Fixion Imn) Model B | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | |
| K010897 | Meridian-Portable | Meridian AG | GZO | Class II | |
| K010847 | K'fix | Avanta Orthopaedics, Inc. | NDL | Class II | |
| K003026 | Pfc Sigma Lugged Tibial Tray | Depuy Orthopaedics Inc. | JWH | Class II | |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model Osr4n229 | Syva Co., Dade Behring, Inc. | LAN | Class II | |
| K011548 | Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and Tdm Control Levels 1, 2, 3 | Medical Analysis Systems, Inc. | JJY | Class I | |
| K011396 | Ibd-Chek | Techlab, Inc. | DEG | Class I | |
| K011211 | Flowable Composite/ Ecuflow/ Luxaflow | Dmg USA, Inc. | EBF | Class II | |
| K010974 | Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet | Corcym Inc. | DWF | Class II | |
| K010870 | Lap Disc 120 X 120, Model Ld111, Lap Disc 120 X 100, Model Ld112, Lap Disc 70 X 70, Model Ld113 | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | Abbott Medical | NBW | Class II | |
| K011623 | Exeter Hip System with V40 Taper | Howmedica Osteonics Corp | JDI | Class II |