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 |
|---|---|---|---|---|---|
| K080189 | Tempa-Kuff Soft Blood Pressure Cuff, Model 39Xxx ; Vinyl,model 99Xxx | Trimline Medical Products Corp. | DXQ | Class II | |
| K080136 | Instant Readout Chemical Integrator Challenge Pack, Model Lt- 105 | Steritec Products, Inc. | JOJ | Class II | |
| K080063 | Mass Casualty Ventilator, Model Mcv100 | Allied Medical LLC | BTL | Class II | |
| K081982 | Watch-Pat 200S-2 (Wp200s-2) | Itamar Medical | MNR | Class II | |
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | MCW | Class II | |
| K081535 | Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K081526 | Flowcare Tlg Reagent | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K081213 | Bd Facscount Cd4 Reagents with Model 339010 | Becton, Dickinson and Company, BD Biosciences | GKZ | Class II | |
| K080544 | Unassigned | Medcomp | FPA | Class II | |
| K082218 | Max Adjusting Instrument | Manna Omni International, Inc. | LXM | Unclassified | |
| K082204 | Series Sy Disposable Electrosurgical Pad | Salter Labs | ODR | Class II | |
| K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | Bioplate Inc | GXN | Class II | |
| K082025 | Body-Jet | Human Med AG | QPB | Class II | |
| K081936 | Solex Catheter, Model Sl2593 | Alsius Corp. | NCX | Class II | |
| K081837 | Avea Ventilator | Cardinal Health 207, Inc. | CBK | Class II | |
| K081459 | Cusa Selector Nxt Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | LFL | Unclassified | |
| K081342 | Reprocessed External Fixation Accessories | Sterilmed Inc | KTT | Class II | |
| K081126 | Parietex Composite Mono Pm Mesh | Sofradim Production | FTL | Class II | |
| K081086 | Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0 | Abbott Medical | BTR | Class II | |
| K080710 | True2go Blood Glucose System, Model F4h01-81 | Home Diagnostics, Inc. | NBW | Class II | |
| K080395 | Sunivf Dishes | <Genx> Intl., Inc. | MQK | Class II | |
| K073432 | Trauson Bone Plate | Trauson (Jiangsu) Medical Instrument Co., Ltd. | HRS | Class II | |
| K082119 | Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K081942 | Neurocath Ag | Phoenix Biomedical Corp. | JXG | Class II | |
| K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K081745 | Echelon Rapid Pv Coil, Model Mr-PVC-150, Echelon Rapid Foot Coil, Model Mr-Rfc-150 and Echelon Rapid Knee Coil | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K081695 | Dmc Composite | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K081647 | Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tips | Xodus Medical Inc | GEI | Class II | |
| K081390 | Bioactif Osteotrans Interfence Screw | Takiron Co., Ltd. | HWC | Class II | |
| K080926 | Aeroeclipse Durable Breath Actuated Nebulizer | Trudell Medical Intl. | CAF | Class II | |
| K080637 | Powerasset Radiofrequency Guidwire, Model Various | Stereotaxis Inc | DQX | Class II | |
| K082148 | Synthes (USA) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (USA) Products LLC | HSB | Class II | |
| K082059 | Angiosculpt Pta Scoring Balloon Catheter | Spectranetics Corp. | PNO | Class II | |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/surgical Face Masks | Primed Medical Products Inc. | FXX | Class II | |
| K081445 | Fora Comfortscan Ear Thermometer, Models Td-1261A; Td-1261B | Taidoc Technology Corporation | FLL | Class II | |
| K081315 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Pink, Black, Grey, and Blue Pepperment) | Gx Corporation Sdn Bhd | LZA | Class I | |
| K080809 | Iec Medsight and Medbright | Innovative Endoscopy Components, LLC. | FET | Class II | |
| K080634 | Access Stfr, Access Stfr Calibrators, and Access Stfr Qc with Models, A32493, A32494, and A32495 | Siemens Healthcare Diagnostics Inc. | DDG | Class II | |
| K080533 | Winco Model Power Series Lift Chair | Winco, Inc. | INO | Class II | |
| K080364 | Findrwirz Guide Wire System | Sentreheart, Inc. | DQX | Class II | |
| K073352 | Weberneedle Basic Laser | Weber Medical GmbH | ILY | Class II | |
| K082028 | Laserpeel Soft-Met Modified Erbium Laser | Global USA Distribution, LLC | GEX | Class II | |
| K081915 | Fdtx Glucose Control Solution | Fujirebio Diagnostics Texas, Inc. | JJX | Class I | |
| K081766 | Pks Omni Instrument | Gyrus ACMI, Inc. | GEI | Class II | |
| K081651 | Instrumed Rongeur | Instrumed International Inc dba Avalign German Specialty Instruments | HAE | Class II | |
| K081476 | Surgical Concept Designs Positionor Surgical Drape | Surgical Concept Designs | KKX | Class II | |
| K081457 | Atrilaze Laser Ablation System | Medical Cv, Inc. | GEX | Class II | |
| K081337 | Approach Cto Wire Guide | Cook Incorporated | DQX | Class II | |
| K081299 | Dimension Vista System Trf Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista | Siemens Healthcare Diagnostics Inc. | DDG | Class II | |
| K081200 | Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4 | Global Top, Inc. | EIH | Class II |