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 |
|---|---|---|---|---|---|
| K203253 | NuVasive ACP System | Nu Vasive, Incorporated | KWQ | Class II | |
| K203087 | CombiDiagnost R90 | Philips Medical Systems DMC GmbH | JAA | Class II | |
| K202452 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | NHA | Class II | |
| K202418 | Magic UCLA Abutment System | Innobiosurg Co., Ltd. | NHA | Class II | |
| K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | MAX | Class II | |
| K201977 | TempTraq | Blue Spark Technologies, Inc. | FLL | Class II | |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | DYW | Class II | |
| K201729 | Medical Mask | Zhende Medical Co., Ltd. | FXX | Class II | |
| K201167 | AireHealth NebulizerTM | Airehealth, Inc. | CAF | Class II | |
| K200404 | ORISE ProKnife | Boston Scientific Corporation | KNS | Class II | |
| K193008 | Tricoglam Home Use | Advihair S.r.l. | OAP | Class II | |
| K203159 | Lux 35 Detector | Eastman Kodak Company | MQB | Class II | |
| K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K203041 | SMS Cementless Stem | Medacta International SA | LZO | Class II | |
| K202835 | Auryon Atherectomy System | Eximo Medical Ltd | MCW | Class II | |
| K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corp. | JOJ | Class II | |
| K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | Hi-Care Thai Gloves Co Ltd | LZA | Class I | |
| K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | K1 Medical, LLC | KCT | Class II | |
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, Inc | KYI | Class II | |
| K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | OLO | Class II | |
| K200572 | Planmeca Romexis | Planmeca Oy | LLZ | Class II | |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | STERIS Corporation | NVE | Class II | |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | |
| K202659 | Stryker Arthroscope | Stryker Corp. | HRX | Class II | |
| K202388 | Apolo D / Apolo S | Vmi Tecnologias Ltda | KPR | Class II | |
| K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co Ltd | LYY | Class I | |
| K202069 | BASE4 Disposable Medical Mask | Base4 Group, Inc. | FXX | Class II | |
| K201712 | Z5-Tl | Z-Systems AG | DZE | Class II | |
| K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K192970 | Slimus | Hironic Co., Ltd. | PKT | Class II | |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | Kimberly-Clark Corporation | LZA | Class I | |
| K201687 | Avenda Health Treatment System | Avenda Health Inc. | GEX | Class II | |
| K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil | Modern Medical Equipment Manufacturing Ltd. | GEI | Class II | |
| K200155 | Bright High Flow | GENOSS Co., Ltd. | EBF | Class II | |
| K203268 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K202851 | Spo2 Sensor | JKH USA, LLC | DQA | Class II | |
| K201653 | Compex Sport Elite 3.0 | DJO, LLC | NGX | Class II | |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | GWG | Class II | |
| K201294 | Pulse Oximeter | Guangdong Long Yao Electronic Technology Co., Ltd. | DQA | Class II | |
| K201173 | E-Guard | Envisiontec GmbH | MQC | Unclassified | |
| K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | JAK | Class II | |
| K202883 | Sterile bone screw (PEEK ACL screw) | Osteonic Co., Ltd. | MBI | Class II | |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K202465 | Night Guard | 3D Diagnostix Inc | MQC | Unclassified | |
| K202306 | T3 Platform software | Etiometry Inc. | MWI | Class II | |
| K202269 | PRE-MILLED Abutment | Mit Global Co., Ltd. | NHA | Class II | |
| K202250 | Dermatological Carbon Dioxide Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | GEX | Class II | |
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | Depuy Ireland UC | MBH | Class II | |
| K202098 | GLOBAL UNITE™ Platform Shoulder System | Depuy Ireland UC | PHX | Class II |