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 |
|---|---|---|---|---|---|
| K091449 | Datascope's 8Fr. 50Cc Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 | Datascope Corp., Cardiac Assist Division | DSP | Class II | |
| K091126 | Vitek 2 Gram Positive Daptomycin | bioMerieux, Inc. | LON | Class II | |
| K091096 | Naturaz Series, Model B16,b20, B42, B60, B98, B100 | Dental Solutions, Inc. | EIH | Class II | |
| K090977 | Piggyback Wire Converter | Vascular Solutions LLC | DQY | Class II | |
| K090958 | Inomax Ds (Delivery System) | Mallinckrodt Manufacturing LLC | MNR | Class II | |
| K090939 | Roche C.f.a.s. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190 | Roche Diagnostics GmbH | DKB | Class II | |
| K090786 | Kens Internal Fixation System | Kens Finemedtech Sdn. Bhd | HRS | Class II | |
| K090745 | Artis Zee / Zeegos with Sw Vc14 | Siemens Medical Solutions USA, Inc. | IZI | Class II | |
| K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | OAT | Class II | |
| K090347 | Camlog Abutments Ps | Altatec GmbH | NHA | Class II | |
| K090307 | Ddi Ultrasonic Nebulizer System | Diagnostic Devices, Inc. | CAF | Class II | |
| K090306 | Aragon Surgical RF System L2 Instrument | Aragon Surgical, Inc. | GEI | Class II | |
| K090167 | Philips Avent Classic Stage 2 and 3 Teether, Model Scf882/01, Scf884/01, Philips Avent Animal Stage 2 and 3 Teether, | Philips Electronics UK Limited | KKO | Class II | |
| K083305 | Powder Free Nitrile Examination Gloves, Sterile with Chemotherapy Claim | WRP Asia Pacific Sdn Bhd | LZC | Class I | |
| K080941 | Bioimpedance Cardiac Analyzing Measuring System | Ni Medical | DSB | Class II | |
| K091591 | Flexicare Medical Endotracheal Tubes | Flexicare Medical Ltd. | BTR | Class II | |
| K091503 | Magnum Mp Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K091466 | 1.9F X 20Cm Vascu-Picc, 1.9F X 50Cm Vascu-Picc, Model Vpi.9s20, Vpi.9s50 | Medcomp | LJS | Class II | |
| K091245 | Costorsol | Preservation Solutions Inc | KDN | Class II | |
| K091132 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | IYE | Class II | |
| K091106 | Equia | GC America Inc. | EMA | Class II | |
| K090848 | Premier Sterile Saline Wound Wash, Models 210 Ml, Wwm | Premier Brands of America Inc. | FQH | Class II | |
| K090843 | Amaris Gingiva Opaquer | Voco GmbH | EBF | Class II | |
| K090837 | Stratapulse Ts and Stratapulse | Advanced Medical Photonics | ONF | Class II | |
| K090763 | Restoris Multicompartmental Knee (Mck) System | Mako Surgical Corp. | NPJ | Class II | |
| K090720 | Cochlear Baha Bp100 | Cochlear Bone Anchored Systems AB | LXB | Class II | |
| K090704 | Multilink Implant | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K090422 | Lucas 2 | Jolife AB | DRM | Class II | |
| K090241 | Synthes Angular Stable Locking System (Asls) | Synthes (USA) Products LLC | HSB | Class II | |
| K090180 | Tender-Trode Prewired Pediatric ECG Electrode | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | DRX | Class II | |
| K082910 | Cvs Silver Bandages, Walgreens Silver Bandages, Xyz Silver Bandages | Aso, LLC | FRO | Unclassified | |
| K082110 | Dual Syringe Holder | Surgin Surgical Instrumentation, Inc. | FMG | Class II | |
| K091581 | Supra 577.Y Laser | Quantel Medical | HQF | Class II | |
| K091161 | Rejuvenate Monolithic Size 4 Hip Stem | Howmedica Osteonics Corp | MEH | Class II | |
| K090721 | Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205 | Medtronic, Inc. | OCL | Class II | |
| K083144 | Acumed Clavicle Screw System | Acumed LLC | JDW | Class II | |
| K083016 | Acthyderm | Microlab Americas, Inc. | EGJ | Class II | |
| K082883 | Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear | I-See Vision Technology, Inc. | LPL | Class II | |
| K082880 | Ezvue (Ocufilcon D) 1-Day Soft (Hydrophilic)contact Lens | I-See Vision Technology, Inc. | LPL | Class II | |
| K082879 | Ezvue (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear | I-See Vision Technology, Inc. | LPL | Class II | |
| K082196 | Static Vessel Analyzer | Imedos GmbH | HKI | Class II | |
| K081720 | Precision Tdp, Heat and Infrared Lamps and Marvel and Wonder Lamps | Prime Herbs Corporation | ILY | Class II | |
| K081150 | Rapidan Optima Early Pregnancy Test and Toyo Pregnancy Test | Turklab Medical Devices, Inc. | LCX | Class II | |
| K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | MQB | Class II | |
| K091484 | Novabone Dental Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | LYC | Class II | |
| K091103 | Guideshot Option for Cxr4 and Eclos CT Systems | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K090706 | Oncentra Simulation 2.3 | Nucletron BV | KPQ | Class II | |
| K090468 | Hamilton-C2 | Hamilton Medical AG | CBK | Class II | |
| K090289 | Clavicle Plating System | TORNIER Inc. | HRS | Class II | |
| K081259 | Ddu-2300 Semiautomatic External Defibrillator and Accessories | Defibtech LLC | MKJ | Class III |