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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | HBE | Class II | |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | GEX | Class II | |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | |
| K222488 | Everyway Analog OTC TENS | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K222309 | Gamma4 System | Stryker Corp. | HSB | Class II | |
| K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc. | NUC | Class II | |
| K222055 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co.,Ltd | FMK | Class II | |
| K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | Ethicon, Inc | GAM | Class II | |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | CAC | Class II | |
| K221558 | ALPHALOK Plating System | Vilex LLC | HRS | Class II | |
| K220535 | Cardio10 | Bionet Co., Ltd. | DPS | Class II | |
| K212700 | Dyflex-II | Taeyeon Medical Co., Ltd. | NKB | Class II | |
| K212612 | Omnia Medical TiBrid-SC | Omnia Medical | OVE | Class II | |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | QNR | Class II | |
| K222749 | High Fluid-Resistant Surgical and Procedure Mask | America'S Supply Chains | FXX | Class II | |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | |
| K222529 | Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | FXX | Class II | |
| K222520 | Zirconia Block | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab Inc | HRX | Class II | |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | Foshan Nanhai Plus Medical Co Ltd | FYA | Class II | |
| K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K221655 | Multiflex Steerable Sheath | Vizaramed, Inc. | DYB | Class II | |
| K221578 | Hexanium ACIF | Spinevision SAS | OVE | Class II | |
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | EMX | Class I | |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | PKL | Class II | |
| K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | HSB | Class II | |
| K213981 | Nitrile Examination Gloves | Emerald Glove Manufacturing Sdn Bhd | LZA | Class I | |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System | Imsonic Medical China, Inc. | IYN | Class II | |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | ETN | Class II | |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems, Inc. | MHC | Class II | |
| K223185 | BreathID® Smart System | Meridian Bioscience Israel Ltd. | MSQ | Class I | |
| K223171 | AquaPulse® Irrigation Tubing | GA Health Company Limited | OCX | Class II | |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | Vivachek Biotech (Hangzhou) Co., Ltd | NFT | Class II | |
| K222551 | Humask Pro Vision, Humask Pro Vision 3000 | Entreprise Premont, Inc. | FXX | Class II | |
| K222504 | H1 | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K222475 | Snor Lock | Solbaro Co.,Ltd. | LRK | Class II | |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | CATALYST ORTHOSCIENCE Inc | KWS | Class II | |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies Ltd | KDI | Class II | |
| K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | MQC | Unclassified | |
| K221678 | SprintRay High Impact Denture Base | Sprintray Inc. | EBI | Class II | |
| K221677 | Synapse 3D Base Tools v6.6 | FUJIFILM Corporation | LLZ | Class II | |
| K221391 | WOLF Thrombectomy™ SmartClaw Catheter | Devoro Medical, Inc. | QEW | Class II | |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K221183 | Aeye-Ds | Aeye Health Inc. | PIB | Class II | |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon ve Ambalaj Malzemeleri | FYA | Class II | |
| K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | EOQ | Class II | |
| K220794 | 10Pl | Tentech Inc. | ONF | Class II | |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | NHA | Class II | |
| K220408 | Aview Rt Acs | Coreline Soft Co., Ltd. | QKB | Class II |