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 |
|---|---|---|---|---|---|
| K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | FINEMEC Co., Ltd | GEX | Class II | |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | ONG | Class II | |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | GMQ | Class II | |
| K182336 | SubtlePET | Subtle Medical Inc | KPS | Class II | |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb Incorporated | LPL | Class II | |
| K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System | Edwards Lifesciences LLC | DXN | Class II | |
| K182218 | FerriSmart Analysis System | Resonance Health Analysis Services Pty Ltd | PCS | Class II | |
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K181784 | Spectra S3 Plus | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K181696 | ChitoZolve | Gyrus ACMI, Inc. | LYA | Class I | |
| K181588 | POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | Jaeger Medical GmbH | BZC | Class II | |
| K181286 | Ambu aScope RLS Slim | Ambu A/S | EOB | Class II | |
| K181221 | BD PhaSeal Optima Closed System Transfer Device | Becton Dickinson & Co | ONB | Class II | |
| K180918 | Planmed Verity | Planmed Oy | OAS | Class II | |
| K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | DQO | Class II | |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | KLW | Class II | |
| K180482 | ZOLL Propaq M | ZOLL Medical Corporation | MHX | Class II | |
| K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc | BZD | Class II | |
| K180298 | welloStationX | Wello, Inc. | FLL | Class II | |
| K173589 | Prizma | G-Medical Innovations, Ltd. | DXH | Class II | |
| K173495 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | QEC | Class II | |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Meridian Bioscience Inc | QDZ | Class II | |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | PDJ | Class II | |
| K182757 | Espire Elbow Pro, Espire Elbow Hybrid | College Park Industries | GXY | Class II | |
| K182587 | Device Electrosurgical Generator ESG-150 | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K182418 | V3 Segmental Plating System | Atlas Spine, Inc. | KWQ | Class II | |
| K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development LLC | OMB | Class II | |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K181880 | VivaSight-SL (TVT) system | Etview, Ltd. | BTR | Class II | |
| K181816 | Ceramic Denture Zirconia Ceramics Block | Qinhuangdao Silide Ceramic Technology Co., Ltd. | EIH | Class II | |
| K181667 | Thoraguard System | Centese Inc. | BTA | Class II | |
| K181427 | BD MAX Enteric Viral Panel, BD MAX Instrument | Becton Dickinson & Co | PCH | Class II | |
| K180685 | AS-3XX Series Fingertip Pulse Oximeter | Xiamen Acurio Instruments Co., Ltd. | DQA | Class II | |
| K173701 | Implant-One System | Implant Logistics, Inc. | DZE | Class II | |
| K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | JWH | Class II | |
| K182992 | BGM014 Blood Glucose Monitoring System | Apex Biotechnology Corp. | NBW | Class II | |
| K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | |
| K181693 | SMS Femoral Stem | Medacta International SA | LZO | Class II | |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | ELW | Class II | |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2M, Inc | MQP | Class II | |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | PML | Class II | |
| K180207 | Non-contact Infrared Thermometer | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K182983 | iFuse Implant System® | SI-Bone, Inc. | OUR | Class II | |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | Integra LifeSciences Corporation | GEI | Class II | |
| K182764 | Biop Digital Colposcope | Biop Medical, Ltd. | HEX | Class II | |
| K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | MAX | Class II | |
| K182369 | gammaCore Sapphire | Electrocore, Inc. | PKR | Class II |