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 |
|---|---|---|---|---|---|
| K180772 | Met One Czar Anterior Cervical Plate System | Met One Technologies, LLC | KWQ | Class II | |
| K172965 | Handheld VitalSigns Monitoring System | Visiomed Technology Co.,Ltd | MWI | Class II | |
| K183162 | Affixus Hip Fracture Nail | Zimmer GmbH | HSB | Class II | |
| K182922 | MTS Omadacycline 0.002-32 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K182905 | UniPulse | Seaward Group | DRL | Class II | |
| K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | MWI | Class II | |
| K182805 | Rct800 | Ray Co., Ltd. | OAS | Class II | |
| K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | DPS | Class II | |
| K182681 | AC5 Topical Gel | ARCH Therapeutics | FRO | Unclassified | |
| K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products | IRP | Class II | |
| K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | |
| K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | |
| K182419 | Centricity Universal Viewer | GE Healthcare | LLZ | Class II | |
| K182354 | SafeAir Telescopic Smoke Pencil | LiNA Medical Inc | GEI | Class II | |
| K182296 | HyperFil-LV | Parkell, Inc. | EBF | Class II | |
| K182207 | Tr90bh | Minxray Inc | IZL | Class II | |
| K182194 | UV Active Implant System | Dio Corporation | DZE | Class II | |
| K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard Inc | FTL | Class II | |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | FEB | Class II | |
| K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | HSB | Class II | |
| K181374 | NRFit Syringe | Jiangsu Caina Medical Co., Ltd | QEH | Class II | |
| K181344 | C.T.M Mobility Scooter | Chien TI Enterprise Co., Ltd. | INI | Class II | |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | PHL | Class II | |
| K181269 | iCertainty | Rfpi | DPW | Class II | |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | Shanghai Venture Bio-Tech Co., Ltd. | DKZ | Class II | |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | HKX | Class II | |
| K180797 | Xcess Guiding Catheter | Curatia Medical Co. | DQY | Class II | |
| K180768 | Arthrex SwiveLock Anchors | Arthrex GmbH | MAI | Class II | |
| K180762 | Capi 3 Hemoglobin(e) | Sebia, Inc. | GKA | Class II | |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | PKP | Class II | |
| K183265 | Selectra Catheters, Selectra Accessory Kit | BIOTRONIK AG | DQY | Class II | |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical Inc. | QAD | Class II | |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | PZI | Class II | |
| K182434 | LaparoGuard | Mariner Endosurgery, Inc. | GCJ | Class II | |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascular Systems Incorporated | MCW | Class II | |
| K182359 | HipCheck | Stryker Corp. | LLZ | Class II | |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | LBI | Class II | |
| K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. | EIH | Class II | |
| K182065 | Evolux Cad/cam Pmma Blocks | Blue Dent Dental | EBG | Class II | |
| K181899 | Roccia® Plif | Silony Medical GmbH | MAX | Class II | |
| K181824 | CBT Screw Fixation System | CG MedTech Co., Ltd. | NKB | Class II | |
| K181463 | DuraSheath Introducer Sheath System | Contract Medical International GmbH | DYB | Class II | |
| K181372 | Argos | Retia Medical, LLC | DXG | Class II | |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | NBW | Class II | |
| K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | DZE | Class II | |
| K180359 | Btl-Fr2000 | BTL Industries, Inc | GEI | Class II | |
| K183383 | ANAX™ OCT Spinal System | CG MedTech Co., Ltd. | NKG | Class II | |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott Medical | DQK | Class II | |
| K182997 | enlighten III Laser System | Cutera Inc | GEX | Class II |