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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K897119 | Grieshaber Retinal Tack and Sutherland Tack Forcep | Grieshaber & Co. | HQW | Class II | |
| K901271 | Lyphochek Urine Toxicology Control - Confirm | Bio-Rad | DIF | Class I | |
| K901233 | Ortho Abnormal Protein C Control Plasma | Ortho Diagnostic Systems, Inc. | GGC | Class II | |
| K900977 | Amresco Inorganic Phosphorus Product #4312500 | American Research Products Co. | CEO | Class I | |
| K900394 | Amresco Bun-Kinetic Reagents Products #7583 | American Research Products Co. | CDQ | Class II | |
| K900304 | Ist-200 Intersegmental Traction Table | Chattanooga Group, Inc. | JFB | Class II | |
| K900277 | Enzymun Test(r) Tsh-S | Boehringer Mannheim Corp. | JLW | Class II | |
| K900245 | Du Pont Vista(r) Immunoassay System | E.I. Dupont de Nemours & Co., Inc. | JJQ | Class I | |
| K896493 | Accuprobe Mycobacterium Tuberculosis Complex Test | Hologic, Inc. | LQF | Class I | |
| K896173 | Ultrascan(r) | Topical Delivery Systems | IYO | Class II | |
| K901489 | Macintosh Laryngoscope Blades (American Profile) | Eastmed Enterprises, Inc. | CCW | Class I | |
| K901474 | Anesthesia Workstation | Siemens Life Support Systems | BRY | Class I | |
| K901317 | Widex Model Q12 Bte with Quatro Remote Control | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K901316 | Widex Model Q9, Bte W/quatro Remote Control | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K901292 | Oticon Bte Hearing Aid (Behind-the-Ear), Model E44 | Oticon, Inc. | ESD | Class I | |
| K901118 | Omniview Digital Radiology Imaging System | Philips North America LLC | LMB | Class I | |
| K901100 | Vectra(tm) | Optical Coating Laboratory, Inc. | HQY | Class I | |
| K900968 | Hearing Aid (All-in-the-Ear) | Audiology of Tulsa, Inc. | ESD | Class I | |
| K900825 | 'Polystim' | Medical Science Products, Inc. | GXY | Class II | |
| K900753 | Shiley Vein Irrigation Cannula (Beveled & Blunt) | Shiley, Inc. | DWF | Class II | |
| K900699 | Flo-Gard 6300 Blood Pumping Indication | Baxter Healthcare Corporation | FRN | Class II | |
| K900578 | Sports Pack Elastics | Lancer Orthodontics, Inc. | EJF | Class I | |
| K900569 | Thermoprobe 210 | Merced Medical, Inc. | BTT | Class II | |
| K900562 | Trans X 100 Chest Film Changer | Acoma Medical Imaging, Inc. | KPR | Class II | |
| K900558 | Pertac Bond | Espe GmbH (US) | KLE | Class II | |
| K900507 | Disposable Screw Type Prophy Brush | Dentsply Intl. | EHK | Class I | |
| K900391 | Fukuda Denshi Model Spirosift 3000 | Fukuda Denshi USA, Inc. | BZG | Class II | |
| K900378 | EMG Option for Microshev 4000 | Micro-Shev, Ltd. | JXE | Class II | |
| K900376 | Hand Surgery and Irrigation Tray (Model 3625) | PMT Corp. | FSM | Class I | |
| K900347 | Birtcher Footcontrolled Suction Coagulator | Birtcher Electro Medical Systems | GEI | Class II | |
| K900345 | Sharplan Nd:yag Lasers for ENT and Neck Surgery | Sharplan Lasers, Inc. | GEX | Class II | |
| K900338 | Visuwell(r) Reagin Test (Modification) | Adi Diagnostics, Inc. | GMQ | Class II | |
| K900302 | Umbilical Cord Blood Sampling Kit | GE Medical Systems Information Technologies, Inc. | CBT | Class I | |
| K900186 | Bonchek-Shiley Cardiac Jacket W/recirculation Set | Shiley, Inc. | DWJ | Class II | |
| K900176 | ENT-2 Flexible Nasopharygno-Laryngoscopes | Machida, Inc. | EOB | Class II | |
| K900032 | Model M1175a/m1176a with St Segment Monitoring | Hewlett-Packard Co. | DRT | Class II | |
| K897075 | Pti Intra-Art(tm) Ansari Saphenous Vein Holder | Pioneering Technologies, Inc. | DXC | Class II | |
| K896438 | Upsizing Lead Adapters 5.0Mm Peel-Away Adapter | Telectronics Pacing Systems, Inc. | DTD | Class II | |
| K896226 | Liss Body Stimulator Model Sbl501-M | Medical Consultants Intl., Ltd. | GZJ | Class II | |
| K896096 | Solostick (Amplatz Dilator Needle) | Microvena Corp. | DRE | Class II | |
| K895888 | Silhouette Porcelain | Leach and Dillon Co., Inc. | EIH | Class II | |
| K895881 | Motionspect | Baltimore Therapeutic Equipment Co. | LXW | Class III | |
| K895524 | Hydrocephalus Shunt System, Low/medium/high Press. | Theramed, Inc. | JXG | Class II | |
| K895433 | Aries 30Cc & 50Cc Intra-Aortic Balloon & Cont. Sys | Aries Medical, Inc. | DSP | Class II | |
| K895267 | Artech Type Ss-Ha Submerged Screw Implant | Artech Corp. | DZE | Class II | |
| K890121 | Modified Dpx Bone Densitometer | Lunar Corp. | KGI | Class II | |
| K901479 | Patient Examination Gloves | Hexza World Trade Sdn. Bhd. | LYY | Class I | |
| K901148 | Latex Examination Gloves | Pt. Scitech Industries | LYY | Class I | |
| K901141 | Paramax 520, Paramax 720 and Paramax 720Zx | Baxter Healthcare Corporation | JJC | Class I | |
| K901136 | Latex Examination Gloves | Qilu (China) Good Luck Chemical Fibers, Inc. | LYY | Class I |