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 |
|---|---|---|---|---|---|
| K051475 | Zoll M Series 12Sl Analysis Option | ZOLL Medical Corporation | MKJ | Class III | |
| K051464 | Planmeca Promax with Dec (Dynamic Exposure Control) | Planmeca Oy | EHD | Class II | |
| K051462 | Modification to: Cercon Base | Dentsply Intl. | EIH | Class II | |
| K051395 | Langston Dual Lumen Pressure Monitoring Catheter | Vascular Solutions LLC | DQO | Class II | |
| K051204 | Bd Phoenix Automated Microbiology System Cefepime (Strep) 0.0625-4Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International Inc | DKB | Class II | |
| K050936 | On Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine | Acon Laboratories, Inc. | LDJ | Class II | |
| K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 Fr, 5 Fr, 6 Fr & 7 Fr | Biosense Webster Inc | DRF | Class II | |
| K050525 | Nxstage System One | NxStage Medical Inc | KDI | Class II | |
| K050434 | Shl Disposable Autoinjector | Shl Medical, USA | KZH | Class II | |
| K051415 | Endotine Ribbon | Coapt Systems, Inc. | GAM | Class II | |
| K051374 | Cardiodrive Catheter Advancement System | Stereotaxis Inc | DQX | Class II | |
| K051363 | Restoration Modular System | Howmedica Osteonics Corp | JDI | Class II | |
| K051349 | 3.0T Prostate Imaging System | Medrad, Inc. | MOS | Class II | |
| K051345 | Colored Powder Free and Polymer Coated Patient Examination Glove (Pink, Blue, Green and Violet) | Glovco (M) Sdn. Bhd. | LYY | Class I | |
| K051283 | Modification to Bernoulli Ventilator Management System Software | Cardiopulmonary Corp. | MSX | Class II | |
| K051243 | Jet Blue Bite | Coltene /Whaledent AG | ELW | Class II | |
| K051202 | Dried Gram-Positive Mic/combo Panels | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K050903 | Xawex G 100 | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K050844 | 750C Series Monitor, Models 750C-2Ms, 750Cm-2Ms, 750C-Nnl, 750Cm-2Nl, 750C-3Ms, 750Cm-3Ms, 750C-3Nl, 750Cm-3Nl | Cas Medical Systems, Inc. | DQA | Class II | |
| K050424 | Ergofilter Spi Accessory to Spirolyser Spl-50 | Fim Medical | BZG | Class II | |
| K041177 | Synthacer; Syntricer | Medartis Medizinprodukte und Forschung AG | MQV | Class II | |
| K051499 | Intravascular Administration Set and Extension Set | Medegen Medical Manufacturing Services | FPA | Class II | |
| K051425 | Nexus Detachable Coil System, Helix Super Soft Csr | Medtronic, Inc. | HCG | Class II | |
| K051284 | Md Turbo | Respirics, Inc. | CAF | Class II | |
| K051254 | Peripheral Cutting Balloon | Boston Scientific Ivt | PNO | Class II | |
| K050852 | Claviculaplate with Angular Stablity Bone Plate System | I.T.S. Implantat-Technologie-Systeme GmbH | HRS | Class II | |
| K050830 | Zodiac Spinal Fixation System | Alphatec/Nexmed | KWP | Class II | |
| K051519 | Fox Sv Pta Catheter (82Xxx Series). Fox Plus Pta Catheter (12Xxx Series) | Abbott Laboratories (Perclose, Inc.) | LIT | Class II | |
| K051502 | Spi Dental Implant | Thommen Medical AG | DZE | Class II | |
| K051483 | Kodak Directview Dr System Detector | Eastman Kodak Company | MQB | Class II | |
| K051335 | Acumatch 12/14 Press-Fit Femoral Stems | Exactech, Inc. | JDI | Class II | |
| K051233 | Omron Model 514N Tympanic Thermometer | Omron Healthcare Co., Ltd. | FLL | Class II | |
| K051207 | Cavex Orthotrace | Cavex Holland B.V. | ELW | Class II | |
| K051183 | Bd Phoenix Automated Microbiology System - Gatifloxacin (Strep) 0.0625 -8Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051148 | Powder-Free Vinyl Patient Examination Gloves | Zibo Sinocare Plastic Products Co., Ltd. | LYZ | Class I | |
| K050860 | Ge Datex-Ohmeda Centiva/5 Ventilator | GE Healthcare | CBK | Class II | |
| K050583 | Model 250 Series Maternal/fetal Monitor | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K050056 | Model 2500A Palmsat Pulse Oximeter | Nonin Medical, Inc | DQA | Class II | |
| K051563 | Nuzone X2a Neoprene - Polyisoprene Powder Free Surgical Gloves Polymer and Aloe Coated | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K051444 | Sentinel Cholinesterase Liquid | Sentinel CH SpA | DIH | Class I | |
| K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K051317 | Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White Color | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | |
| K051154 | Powdered Vinyl Patient Examination Gloves, White (Non-Colored) | Hebei Manful Import & Export Co., Ltd. | LYZ | Class I | |
| K051021 | Aneroid Sphygmanometer with Stethoscope, Model Hs-50A | Shanghai Lord International Trade Co., Ltd. | DXQ | Class II | |
| K050995 | Revolution 45 Mhz Rotational Ivus Imaging Catheter | Volcano Corporation | OBJ | Class II | |
| K050805 | 30 Ml or 60 Ml Pedi-Syringe Filter | Blood Products Specialties, LLC | BRZ | Class II | |
| K043314 | Manzi Cleaner System | Langford IC Systems, Inc. | NVE | Class II | |
| K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | IYO | Class II | |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin Tests | Arkray, Inc. | CIG | Class II |