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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | LJM | Class II | |
| K182169 | AdVance XP Male Sling | Boston Scientific Corporation | OTM | Class II | |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic CryoCath LP | DRA | Class II | |
| K183159 | 3M Clarity Aligners | 3M Company | NXC | Class II | |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | LLZ | Class II | |
| K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | |
| K183009 | Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades | Hemostatix Medical Technologies, LLC | GEI | Class II | |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel MedTech (Suzhou) Co., Ltd. | LOX | Class II | |
| K182470 | Plateau Spacer System | Life Spine | MAX | Class II | |
| K182431 | Konicaminolta DI-X1 | Konica Minolta, Inc. | LLZ | Class II | |
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | MBH | Class II | |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | QEY | Class II | |
| K182134 | ARiX RAD Radiographic System | Compania Mexicana de Radiologia CGR, S.A. de C.V. | KPR | Class II | |
| K181112 | Orchestrate 3D | Orchestrate 3D | PNN | Class II | |
| K172837 | Low-frequency Multi-function physiotherapy instrument | Shenzhen Osto Technology Company Limited | NUH | Class II | |
| K182967 | Visor System | Cerebrotech Medical Systems | QAF | Class II | |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | |
| K182684 | HammerTechTM Fixation System | Fusion Orthopedics, LLC | HWC | Class II | |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Contamac Ltd. | HQD | Class II | |
| K181443 | Accula RSV Test | Mesa Biotech, Inc. | OCC | Class II | |
| K181381 | A.B. Dental Devices Dental Implants System | A.B. Dental Device, Ltd. | NHA | Class II | |
| K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) | Medcu Technologies Ltd. | FRO | Unclassified | |
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | Kronus, Inc. | PCG | Class II | |
| K180573 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy | HWC | Class II | |
| K180557 | Greene Renal Transplant Stent Set | Cook Incorporated | FAD | Class II | |
| K180430 | Digistat Smart Central | Ascom Ums SRL Unipersonale | MSX | Class II | |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co.,Ltd | HJO | Class II | |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | FMZ | Class II | |
| K182957 | Heli-FX EndoAnchor System | Medtronic, Inc. | OTD | Class II | |
| K182909 | Roth Net Retriever Product Line | United States Endoscopy Group, Inc. | FDI | Class II | |
| K182779 | ARK EDDP Assay | Ark Diagnostics Inc | DJR | Class II | |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies ULC. (Now A Part of Stryker) | GCJ | Class II | |
| K182581 | PlayMakar Sport Muscle Stimulator, Model PRO-500 | Playmakar, Inc. | NUH | Class II | |
| K182352 | SP-LINK™ System | Medical Designs, LLC | PEK | Class II | |
| K182277 | Versana Premier | GE Healthcare | IYN | Class II | |
| K182027 | Wet Organics Personal Lubricant | Trigg Laboratories dba Wet International | NUC | Class II | |
| K181996 | MATRx Plus | Zephyr Sleep Technologies | MNR | Class II | |
| K181704 | Transpara | Screenpoint Medical | QDQ | Class II | |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal | Alcon Laboratories | LPL | Class II | |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | HDX Will | MUH | Class II | |
| K181123 | ApnoDent Appliance | Apnomed, Inc. | LRK | Class II | |
| K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | LJS | Class II | |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K173744 | ProFuse CAD | Eigen | LLZ | Class II | |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | Steris Corporations | FRC | Class II | |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | IYN | Class II | |
| K182696 | Telepack X LED | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 | Kangfu Medical Equipment Factory | FLL | Class II | |
| K182291 | 6MP Color LCD Monitor (C61W+) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K182288 | TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona Inc | EBF | Class II |