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 |
|---|---|---|---|---|---|
| K063315 | Intellivue Patient Monitors, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 and Mp90 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K062938 | Microscan Synergies Plus Gram-Positive Mic/combo Panels with Nitrofurantoin (2 - 256 Ug/ml | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279 | Medicon Hellas SA | DBF | Class II | |
| K062237 | Cadi, Version 4 | Synca Marketing | LLZ | Class II | |
| K061101 | D3 Ultra Dfa Respiratory Virus Screening & Id Kit | Ortho-Clinical Diagnostics, Inc. | GNW | Class I | |
| K063389 | Go Go Elite Traveller Plus 4 Wheel Scooter, Model Sc54 | Pride Mobility Products Corp | INI | Class II | |
| K063373 | Flex Loop Coil Set 3T | Siemens Corp. | MOS | Class II | |
| K063283 | Definium 5000 X-Ray System | Sedecal S.A. | MQB | Class II | |
| K063280 | Injekt Syringe | B.Braun Medical, Inc. | FMF | Class II | |
| K063185 | Rii Infrared Ear Thermometer, Models Th5xy Series | Radiant Innovation Inc. | FLL | Class II | |
| K063046 | Nitrile Powder Free Examination Gloves (Green) | Hartalega Sdn Bhd | LZA | Class I | |
| K062906 | Ena Hfo Composite System | Micerium S.p.A. | EBF | Class II | |
| K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed | MQN | Class II | |
| K062523 | Tru-Mr Laryngoscope Set | Truphatek International, Ltd. | CCW | Class I | |
| K062510 | Aesculap Sterilcontainer System | Aesculap Inc | FRG | Class II | |
| K062493 | Lava Software | 3M Espe AG Dental Products | NHA | Class II | |
| K062487 | Aperfix Femoral Implant with Inserter | Cayenne Medical Inc. | HWC | Class II | |
| K062416 | Retinal Functional Imager (Rfi) | Optical Imaging, Ltd. | HKI | Class II | |
| K062399 | Rockwell Medicaltechnologies, Inc. Citrapure | Rockwell Medical | KPO | Class II | |
| K062131 | Nio 5Mp-M-21 (Nio 5Mp Mammo); Mdng-5121 Bb | Barco N.V. | LLZ | Class II | |
| K061829 | Electrosurgical Cutting and Coagulation Device and Accessories | New Leaf Medical, Inc. | GEI | Class II | |
| K061601 | Asahi Precious Guide Catheter | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K061375 | Respirator N95 Particulate Respirator, Model 1730 | Louis M. Gerson Co., Inc. | MSH | Class II | |
| K063289 | 2Mp Medical Monochrome Reference Display, Model Mdm2130-2Nc | Chi Lin Technology Co., Ltd. | LLZ | Class II | |
| K062934 | Sierra | Seaspine, Inc. | MNI | Class II | |
| K062643 | Kinetic Anterior Cervical Plate | Life Spine | KWQ | Class II | |
| K062400 | Impressix, Colorchange Alginate | Cavex Holland B.V. | ELW | Class II | |
| K062123 | Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, Fs Calibrator 1 and Dat Performance Verifiers I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | DIO | Class II | |
| K061933 | Hager Miramatic Box Sharps Container and Cap Trap Needle Re-Capper | Hager Worldwide, Inc. | FMI | Class II | |
| K053524 | C-Port Distal Anastomosis System | Cardica, Inc. | FZP | Class II | |
| K052716 | Rapirun H. Pylori Antibody Detection Kit | Otsuka Pharmaceutical Co., Ltd. | LYR | Class I | |
| K063302 | Sdif Dental Chair with Operative Unit and Accessories | Shanghai Dental Instrument Factory Co., Ltd. | EIA | Class I | |
| K062944 | Bd Phoenix Automated Microbiology System - Ceftriaxone (Gn) 0.5-64Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | DPS | Class II | |
| K062419 | Trident Large Diameter Acetabular Inserts | Howmedica Osteonics Corp | LPH | Class II | |
| K062065 | Riva Luting Plus | Southern Dental Industries, Inc. | EMA | Class II | |
| K061002 | Maxima Anterior Cervical Plate System | CG MedTech Co., Ltd. | KWQ | Class II | |
| K053420 | Tenacore Sp02 Sensors | Tenacore Holdings, Inc. | DQA | Class II | |
| K063252 | Atb Advanced Pta Dilatation Catheter | Cook Inc. | DQY | Class II | |
| K063222 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model Cn1004 | Cardionet, LLC | QYX | Class II | |
| K063204 | Spiderfx Embolic Protection Device | Medtronic, Inc. | NTE | Class II | |
| K063158 | Synthes Antegra System | Synthes Spine Co.Lp | KWQ | Class II | |
| K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K062871 | Lumacare Lc-122M Non-Coherent Light Source | Lynton Lasers Limited | GEX | Class II | |
| K062619 | Denlaser 800 Plus | Cao Group, Inc. | GEX | Class II | |
| K062441 | Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010; Footswitch, Model 90-9020 | Barrx Medical, Incorporated | GEI | Class II | |
| K062403 | Imax Ceph Digital X-Ray Sensor | Owandy Inc. | MUH | Class II | |
| K062262 | Ciba Vision (Sifilcon a) Spherical, Toric, Multifocal and Multifocal Toric Designs | Alcon Laboratories | LPL | Class II | |
| K062074 | Iridex Wireless Footswitch | Iridex Corporation | HQF | Class II | |
| K063144 | Vitros 5,1 Fs Chemistry System with Engen Laboratory Automation System | Ortho-Clinical Diagnostics, Inc. | JJE | Class I |