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 |
|---|---|---|---|---|---|
| K060752 | Acmi Dur-Hl Laser Systems | Acmi Corporation | GEX | Class II | |
| K060746 | Memory Staple | Depuy Orthopaedics Inc. | JDR | Class II | |
| K060726 | Powder Free Nitrile Examination Glove Coated with Cucumber with Glycerine (Blue Color) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K060723 | 40 L High Flow Insufflator F113 | Novanta Medical GmbH | HIF | Class II | |
| K060713 | Proceed Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K060647 | Ltv 1200 Ventilator | Pulmonetic Systems, Inc. | CBK | Class II | |
| K060525 | Vanguard Removable Molded Poly Tibia | Biomet Manufacturing Corp | JWH | Class II | |
| K060506 | Stryker Spine Vlift Vertebral Body Replacement System | Howmedica Osteonics Corp | MQP | Class II | |
| K060324 | Bd Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 Ug/ml - Gram-Negative | Becton Dickinson & Co | LON | Class II | |
| K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11) | Vision Biosystems, Inc. | MYA | Class II | |
| K060157 | Immuglo Anti-Endomysial Antibody Ifa | Immco Diagnostics, Inc. | MVM | Class II | |
| K060128 | Clearblue Easy Digital Pregnancy Test | Unipath, Ltd. | LCX | Class II | |
| K053452 | Pure-Aid Pregnancy Test | Bio Focus Co., Lt. | LCX | Class II | |
| K053359 | Rapidtox | American Bio Medica Corp. | DKZ | Class II | |
| K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes | AD-Tech Medical Instrument Corp. | GZL | Class II | |
| K061132 | Modification to Superopen 0.35T, Model Nsm-P035 | Neusoft Medical Systems Co., Ltd. | LNH | Class II | |
| K061098 | Ebi Optilock Periarticular Plating System | Ebi, LLC | HRS | Class II | |
| K061074 | Able Glove, Nitrile Blue Powdered Examination Gloves | Bright Element Sdn Bhd | LZA | Class I | |
| K061022 | Bio 1-Kit Biosorb Filled Cartridge | Science for Biomaterials | MQV | Class II | |
| K060977 | Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523 | Hoya Conbio, Inc. | GEX | Class II | |
| K060909 | Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) | Jiangsu Everyguard Plastic Products Co., Ltd. | LYZ | Class I | |
| K060805 | Modification to Given Diagnostic System | Given Imaging Ltd. | NSI | Class II | |
| K060552 | Bc100 Body Composition Analysis System | Athletic Iq, Inc. | MNW | Class II | |
| K060535 | Spacer-S Temporary Shoulder Spacer | Tecres SpA | HSD | Class II | |
| K060381 | Allient Sorbet Hemodialysis System, Model 1100 | Renal Solutions, Inc. | FKT | Class II | |
| K053539 | Meridian Hemodialysis Machine, Model 5M5576 | Baxter Healthcare Corporation | KDI | Class II | |
| K052674 | Contact Lens Ophthalmodynamometer | Meditron AS | NYK | Class II | |
| K052511 | Cardiofax Ce, Model ECG-1500 a | Nihon Kohden America Inc | DPS | Class II | |
| K051442 | Photosilk Plus Pulsed Light System and Laser Attachment | Cynosure, LLC | GEX | Class II | |
| K050367 | Biophen Heparin 3, Biophen Heparin 6 | Hyphen Biomed Sasu | KFF | Class II | |
| K061273 | 7000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200L | Nova Ortho-Med Inc | IOR | Class I | |
| K061264 | Tempfx Esthetic Provisional System | Dentsply International, Inc. | EBG | Class II | |
| K061192 | Blue Colour Powder Free Barrierpro Polymer Bp2000 Polybutadiene Copolymer Examination Gloves | Ethicon Endo-Surgery Inc | LZA | Class I | |
| K061175 | Claris I310d Intraoral Camera System & Accessories | Sota Precision Optics, Inc. | EIA | Class I | |
| K061127 | Cg Future Annuloplasty System, Model 638R | Medtronic, Inc. | KRH | Class II | |
| K061125 | Dvtcare Ca5 | Doctors Orders | JOW | Class II | |
| K061113 | Orthomon | Axon Systems, Inc. | GWF | Class II | |
| K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model Bsq-RF-32 | MAQUET CARDIOPULMONARY GmbH | KFM | Class II | |
| K061010 | Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair | Future Mobility Healthcare Inc. | IOR | Class I | |
| K060822 | Vantage Indirect Ophthalmoscope | Keeler Instruments, Inc. | HLI | Class II | |
| K052404 | Denali Deformity System | K2M, Inc | KWP | Class II | |
| K052299 | Reprocessed Endoscopic Trocar | Sterilmed Inc | NLM | Class II | |
| K061191 | Finger and Ear Sensors and Neonatal-Adult and Adult/pediatric Adhesive Sensors for Use with Nellcor R-Cal Spo2 | Measurement Specialties, Inc. | DQA | Class II | |
| K061128 | Modification to Medrad Continuum Mr Infusion System | Medrad, Inc. | FRN | Class II | |
| K061112 | Conmed Pro2 Pulse Reflectance Oximeter, Model Pro-M | ConMed Corporation | DQA | Class II | |
| K060995 | Duckworth & Kent Ltd Lens Delivery System, Model Dk7788 | Duckworth & Kent, Ltd. | MSS | Class I | |
| K060994 | Mondial | Kulzer GmbH | ELM | Class II | |
| K060928 | Cryoshape | Etgar Group H.M.Y.A., Ltd. | GEH | Class II | |
| K060649 | Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000 | Tyco Healthcare Group LP | FLL | Class II | |
| K060530 | Sd Ceramic Coping for Quick Abutment, Locking. Model 45301. Rd Ceramic Coping for Quick Abutment, Locking, Model 45302. | Lifecore Biomedical LLC | ELL | Class II |