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 |
|---|---|---|---|---|---|
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | OUO | Class II | |
| K193085 | PuraDERM Gel | 3-D Matrix, Inc. | FRO | Unclassified | |
| K193043 | Critical Alert CommonPath Enterprise | Critical Alert | MSX | Class II | |
| K192244 | Arcad SmileStudio and Aligner System | Arcadlab | NXC | Class II | |
| K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | GEI | Class II | |
| DEN190031 | NP Screen | Advance Sentry Corporation | OJY | Class II | |
| K200659 | Dermalux Tri-Wave MD | Aesthetic Technology Ltd | GEX | Class II | |
| K200964 | Sonosite PX Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K200950 | Ventricular Catheter | Aesculap Inc | JXG | Class II | |
| K200935 | Mazor X | Mazor Robotics Ltd | OLO | Class II | |
| K200640 | Altapore Shape | Baxter Healthcare Corporation | MQV | Class II | |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis Inc. | PLV | Class II | |
| K193617 | Precice® Screws | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K193016 | PRECICE Bone Transport System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K192218 | Custom Legacy and Custom InterActive Titanium Abutments | Implant Direct Sybron Manufacturing LLC | NHA | Class II | |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K200966 | Icare HOME Tonometer | Icare Finland Oy | HKY | Class II | |
| K200699 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K200653 | AMF Revision TT Cones | Lima Corporate S.p.A. | JWH | Class II | |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | IYE | Class II | |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | JWH | Class II | |
| K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Medtronic, Inc. | GEI | Class II | |
| K200120 | LiteSaber Wire Torque Assist Device | Vesatek, LLC | DQX | Class II | |
| K193535 | EZER, Portable X-ray System | Livermoretech,Inc | IZL | Class II | |
| K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K192866 | Chemfort CSTD | Simplivia Healthcare Ltd. | ONB | Class II | |
| K192693 | Nuvo Nano Portable Oxygen Concentrator | Nidek Medical Products Inc | CAW | Class II | |
| K192651 | ZAGA Zygomatic System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | GBM | Class II | |
| K201058 | Accuvue+ | RadmediX, LLC | MQB | Class II | |
| K193496 | CharmFil | Dentkist, Inc. | EBF | Class II | |
| K193420 | XO Cross Support Catheter | Transit Scientific, LLC | DQY | Class II | |
| K193189 | RFID Localization System | Health Beacons, Inc. | NEU | Class II | |
| K192586 | LIAISON® Folate | Diasorin Inc. | CGN | Class II | |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | DRE | Class II | |
| K192069 | Aerodentis System | Dror Orthodesign | NXC | Class II | |
| K201184 | Lascod Impression Materials | La.sc.od. SpA | ELW | Class II | |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corp. | JDW | Class II | |
| K200914 | Healix Compression Screw System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K200846 | Balteum™ Lumbar Plate System | Huvexel Co., Ltd. | KWQ | Class II | |
| K200546 | ZeeroMED View | O3 Enterprise SRL | LLZ | Class II | |
| K200315 | Ziostation2 | Ziosoft, Inc. | LLZ | Class II | |
| K200293 | InMode System with vTone Applicator | Inmode Ltd. | KPI | Class II | |
| K193220 | Aview Lcs | Coreline Soft Co., Ltd. | LLZ | Class II | |
| K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K191590 | AA temp temporary restoration 3D printing photoreactive resin | Enlighten Materials Co., Ltd. | EBG | Class II | |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | QEZ | Class II | |
| K200259 | Headless Compression Screw System | Osteocentric Extremities, LLC | HWC | Class II |