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 |
|---|---|---|---|---|---|
| K152350 | Regular and Special Umbilical Cord Clamp and Cutter | Ningbo Feite Medical Device Co., Ltd. | NBZ | Class II | |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | Boston Scientific Corporation | FEQ | Class II | |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | Guangzhou Wondfo Biotech Co., Ltd. | DIO | Class II | |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IYN | Class II | |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | FAS | Class II | |
| K161476 | SMR Shoulder System | Lima Corporate S.p.A. | KWT | Class II | |
| K161421 | Single Use Surgical Suction Irrigator | Jiangsu Haize Medical Scientific Development Co.,Ltd. | GCJ | Class II | |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Philips North America LLC | MSX | Class II | |
| K161146 | Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | |
| K161144 | iDMS Data Management System | Accuray Incorporated | IYE | Class II | |
| K161136 | Precision Treatment Planning System | Accuray Incorporated | MUJ | Class II | |
| K160891 | Ultrathane Endoureterotomy Stent Set | Cook Incorporated | FAD | Class II | |
| K160669 | ClariFix Device | Arrinex, Inc. | GEH | Class II | |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Synaptive Medical Inc | HAW | Class II | |
| K160511 | Naya Breast Pump System | Naya Health, Inc. | HGX | Class II | |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | Medrad, Inc. | NBW | Class II | |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (dba Synermed) | CGA | Class II | |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | ODP | Class II | |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | SD Biosensor, Inc. | NBW | Class II | |
| K153033 | Digital Blood Pressure Monitor | Suzhou Sunspiri Co., Ltd. | DXN | Class II | |
| K152843 | Liger Medical HTU-110 | Liger Medical | HGI | Class II | |
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | PNV | Class II | |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | Owen Mumford Limited | FMI | Class II | |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | Alfa Scientific Designs, Inc. | DKZ | Class II | |
| K161559 | Kuvia3D | 4qimaging, LLC dba Qmetrics | LLZ | Class II | |
| K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | NHB | Class II | |
| K160823 | NC Quantum Apex PTCA Dilatation Catheter | Boston Scientific Corporation | LOX | Class II | |
| K160805 | Nio-P | Waismed Ltd. | FMI | Class II | |
| K160602 | JustRight Surgical Vessel Sealing System | Bolder Surgical, LLC | GEI | Class II | |
| K160540 | Flexicare Neonatal Heated Wire Breathing System | Flexicare Medical Ltd. | BZE | Class II | |
| K160468 | Synthetic Vinyl Examination Gloves, Powder-Free, Yellow | Inpro Technology Device Factory | LYZ | Class I | |
| K160169 | The Life Spine Subtalar Implant System | Life Spine | HWC | Class II | |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | NBW | Class II | |
| K153682 | Chocolate XD PTCA Balloon Catheter | Trireme Medical, Inc. | LOX | Class II | |
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | HAM | Class II | |
| K153353 | Sandman Elite | Embla Systems | OLZ | Class II | |
| K153057 | FitRite™ Total Hip Arthroplasty System | Excera Orthopedics, Inc. | JDI | Class II | |
| K153018 | Celalux 3 | Voco GmbH | EBZ | Class II | |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | Sterilmed Inc | NLH | Class II | |
| K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc | KGN | Unclassified | |
| K150404 | QiF Blood and Fluid Warmer | Quality in Flow Ltd. | LGZ | Class II | |
| K161429 | Target Detachable Coils | Stryker Corp. | HCG | Class II | |
| K161325 | CliniCloud Non-contact Thermometer, Model SPL1024 | Stethocloud Pty.Ltd (Clinicloud) | FLL | Class II | |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | ERL | Class II | |
| K161061 | IMPAX Volume Viewing 4.0 | AGFA Healthcare Corp. | LLZ | Class II | |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | |
| K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | Liofilchem S.r.l. | JWY | Class II | |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical Electric Co., Ltd | HJO | Class II | |
| K152967 | Nerbridge | Toyobo Co., Ltd. | JXI | Class II |