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 |
|---|---|---|---|---|---|
| K200032 | ReWalk P6.0 | Re Walk Robotics, Ltd. | PHL | Class II | |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | OZR | Class II | |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | LPN | Class II | |
| K192392 | DiaPlus | Diadent Group International | KLE | Class II | |
| K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | EFB | Class I | |
| K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | NKG | Class II | |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming | CC Wellness LLC | NUC | Class II | |
| K200419 | Kalera Vacuum Aspiration Catheter (K-VAC) | Kalera Medical, Inc. | FED | Class II | |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | OBJ | Class II | |
| K200246 | JPS JuniOrtho Plating System | Orthofix SRL | HRS | Class II | |
| K200126 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | NKB | Class II | |
| K192560 | Surgical Gown | Shandong Kangli Medical Equipment Technology Co., Ltd. | FYA | Class II | |
| K192488 | CO2 Sidestream Module | Beijing Kingst Commercial & Trade Co., Ltd. | CCK | Class II | |
| K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps | Adeor Medical AG | GEI | Class II | |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | Boston Scientific Corporation | LJT | Class II | |
| DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica Corp. | QKZ | Class II | |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp. | FFX | Class II | |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | HEW | Class II | |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface | Medtronic, Inc. | KFM | Class II | |
| K200995 | Insignia™ Anterior Cervical Plate System | Alphatec Spine, Inc. | KWQ | Class II | |
| K200969 | NEXXT MATRIXX System | Nexxt Spine LLC | MAX | Class II | |
| K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | KWQ | Class II | |
| K200751 | Photodynamic Therapy (PDT) Equipment | Shangdong Huamei Technology Co., Ltd. | GEX | Class II | |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies ULC. (Now A Part of Stryker) | OWN | Class II | |
| K200662 | X-Guide® Surgical Navigation System | X-NAV Technologies, LLC | PLV | Class II | |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | FBN | Class II | |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora, Ltd. | PBX | Class II | |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | ORZ | Class II | |
| K200274 | CariCloud | Caristo Diagnostics | LLZ | Class II | |
| K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MSX | Class II | |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | |
| K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | CCK | Class II | |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | Hangzhou AGS MedTech Co., Ltd. | KNS | Class II | |
| K192265 | gi-4000 Electrosurgical Generator | United States Endoscopy Group, Inc. | GEI | Class II | |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | GBM | Class II | |
| K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | KWQ | Class II | |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co Ltd | ESW | Class II | |
| K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies Ltd | OVD | Class II | |
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company, LLC | DHR | Class II | |
| K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | LIT | Class II | |
| K191362 | LifeFlow Blood System | 410 Medical Inc. | FPA | Class II | |
| K201124 | TOPAZ Mobile DR System | DRGEM Corporation | IZL | Class II | |
| K200864 | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K200749 | CUBEScan BioCon-900S | MCUBE TECHNOLOGY Co.,Ltd. | IYO | Class II | |
| K200303 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB | Class II | |
| K192016 | Smoov O10 | Alber GmbH | ITI | Class II | |
| K201062 | syngo Ultrasound Apps Suite (sUSAS) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated | OMB | Class II |