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 |
|---|---|---|---|---|---|
| K013061 | Biotouch Massage Therapy System | Tactile Systems Technology Inc | IRP | Class II | |
| K011220 | Leveen Reflect Monopolar/bipolar Needle Electrode | Radiotherapeutics Corp. | GEI | Class II | |
| K011037 | Vertebral Spacer | Synthes (USA) Products LLC | MQP | Class II | |
| K021943 | Onetouch Profile Blood Glucose Monitoring System | Lifescan, Inc. | CGA | Class II | |
| K021754 | Apex Medical Digital Ems Ts1311, Ts1312 | Apex Medical, Inc. | IPF | Class II | |
| K021345 | Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis US Corp. | FGE | Class II | |
| K021305 | Microlife Wrist Watch Blood Pressure, Model Bp-3Bu1-5, with Optional Thermal Printer | Microlife Corp. | DXN | Class II | |
| K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation and Pip, Model 9100 | Vista Medical Technologies, Inc. | GCJ | Class II | |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244 | Siemens Healthcare Diagnostics Inc. | DDR | Class II | |
| K021140 | Fossa Expanding Double Pigtail Ureteral Stent | Fossa Industries, Inc. | FAD | Class II | |
| K021097 | Quest Exercise Stress System (Quest), Version 3.52 | GE Healthcare | DSI | Class II | |
| K020932 | Devilbiss Pulmo-Aide Compact Compressor | Sunrise Medical, Inc. | CAF | Class II | |
| K020382 | Blue Sensor, Disposable ECG Electrodes for Anaesthesia | Medicotest, Inc. | DRX | Class II | |
| K020211 | Body Force, Model Bt 6000 | Composites Solutions, Inc. | JOW | Class II | |
| K002159 | Snore Sat Recorder, Model Ss41 | Sagatech Electronics, Inc. | MNR | Class II | |
| K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | EWO | Class II | |
| K021797 | L.e.demetron | Sybron Dental Specialties, Inc. | EBZ | Class II | |
| K021756 | Welch Allyn Abpm 6100 | Welch Allyn Inc | DXN | Class II | |
| K021609 | Rdi Hs Crp Kit | Reference Diagnostics, Inc. | DCK | Class II | |
| K021607 | Rdi Hs Crp Calibrator Set | Reference Diagnostics, Inc. | JIT | Class II | |
| K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | Bayer Diagnostics Corp. | JIT | Class II | |
| K021532 | Advia Centaur and Acs:180 C-Peptide Calibrator | Bayer Diagnostics Corp. | JIT | Class II | |
| K021480 | Extension Set Light-Safe, Model Bc565 | Codan US Corp. | FPA | Class II | |
| K021373 | H12+holter Recorder | Mortara Instrument, Inc. | MWJ | Class II | |
| K021288 | Ors-1000Ld | O.R. Solutions, Inc. | LHC | Class I | |
| K021141 | Millennium 5000 Meurovascular Coil | GE Healthcare Coils | MOS | Class II | |
| K021099 | Rex, Version 1.0 | Pointdx, Inc. | LLZ | Class II | |
| K020979 | Sysmex Automated Coagulation Analyzer, Model #Ca-7000 | Siemens Healthcare Diagnostics Inc. | GKP | Class II | |
| K013613 | Soft Plug Absorbable Plug-Sa | Oasis Medical, Inc. | LZU | Unclassified | |
| K012669 | Reprocessed Electrosurgical Electrodes | Surgical Instruments Service and Savings, Inc. | GEI | Class II | |
| K003720 | Angel of Water Colon Hydrotherapy System | Lifestream Purfication Systems, LLC | KPL | Class II | |
| K021880 | Crossover Cross Connector (Moss Miami Spine System) | Depuyacromed | MNH | Class II | |
| K021879 | Crossover Cross Connector (Isola Spinal System) | Depuyacromed | MNH | Class II | |
| K021832 | Arthrotek Resorbable No-Profile Lactosorb L-15 Screw & Washer | Zimmer GmbH | HWC | Class II | |
| K021799 | Cemented Femoral Head Resurfing Device | Biomet Orthopedics, Inc. | KXA | Class II | |
| K021748 | Endius Atavi System | Endius, Inc. | HRX | Class II | |
| K021744 | T2 Femoral Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K021741 | Critertion, Model #1067511 | Sterngold | EJT | Class II | |
| K021733 | Autopal 50 | Wieland Dental + Technik GmbH & Co. KG | EJT | Class II | |
| K021684 | The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | Bioplate Inc | JEY | Class II | |
| K021299 | Conmed Heatwave Hand-Controlled Eletrode | Conmedcorp | GEI | Class II | |
| K021289 | Warmer 2000Ld | O.R. Solutions, Inc. | LHC | Class I | |
| K021227 | Softlase G2-Surgical Diode Laser System | Zap Lasers, LLC | GEX | Class II | |
| K021223 | Belimed Steam Sterilizer, Model Top 5000 | Sauter AG | FLE | Class II | |
| K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | GEH | Class II | |
| K021168 | Jump Start, Model 970300 | Medical Research Laboratories, Inc. | MKJ | Class III | |
| K021137 | Sanarus Centrica Core Tissue Biopsy System | Sanarus Medical, Inc. | KNW | Class II | |
| K021050 | Ksea Neuroendoscopes and Accessories | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K021045 | Era Implant | Sterngold | DZE | Class II | |
| K021036 | Intuitive Surgical Da Vinci Surgical System, Model Is1000 | Intuitive Surgical, Inc. | NAY | Class II |