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 |
|---|---|---|---|---|---|
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | HKI | Class II | |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | Exactech, Inc. | HSN | Class II | |
| K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | LPH | Class II | |
| K181597 | Le'Pen | Kmihh, Ltd. | EBZ | Class II | |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | FET | Class II | |
| K190178 | Monaco RTP System | Elekta Limited | MUJ | Class II | |
| K190023 | Btl-084 | BTL Industries, Inc | PBX | Class II | |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation Corporation | GZF | Class II | |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Applied Medical Technology Inc | KNT | Class II | |
| K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | GE Medical Systems SCS | LLZ | Class II | |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott Medical | MXC | Class II | |
| K182965 | BL-Cart IOL Delivery Cartridge | AST Products, Inc. | MSS | Class I | |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | JAA | Class II | |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | GZB | Class II | |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao de | JEY | Class II | |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | Microtek Medical LLC | NHV | Class II | |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | DJG | Class II | |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | JOZ | Class II | |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | LKF | Class II | |
| K181352 | Loop System | Spry Health, Inc. | DQA | Class II | |
| K180924 | Reflect Implant System | Ids - Integrated Dental Systems | DZE | Class II | |
| K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | MWI | Class II | |
| K190303 | AirSeal | ConMed Corporation | HIF | Class II | |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | PT. Medisafe Technologies | KGO | Class I | |
| K181745 | FUJIFILM Duodenoscope Model | FUJIFILM Corporation | FDT | Class II | |
| K181505 | V.A.C. DERMATAC Drape | KCI USA, Inc. | OMP | Class II | |
| DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | QFX | Class II | |
| DEN180012 | LOADPRO™ Intraoperative Rod Strain Sensor | Intellirod Spine, Inc. | QFP | Class II | |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | CHH | Class I | |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy | MBI | Class II | |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit | Centers for Disease Control and Prevention | OZE | Class II | |
| K190242 | Tyto Thermometer | Tyto Care Inc. | FLL | Class II | |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | Current Health Inc | MSX | Class II | |
| K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K183105 | Mimics Medical | Materialise N.V. | LLZ | Class II | |
| K182835 | WOLF Thrombectomy Device | 880 Medical, LLC | QEW | Class II | |
| K182821 | Accutorr 7/VS-900/VS-900c Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MWI | Class II | |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co.,Ltd | DKZ | Class II | |
| K181929 | MiMo(TM) Negative Pressure Wound Therapy System | Baymax Research, Inc. | OMP | Class II | |
| K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | DQD | Class II | |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | LJE | Unclassified | |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | NQQ | Class II | |
| K190392 | WaveLight FS200 Patient Interface | Alcon Laboratories | GEX | Class II | |
| K190232 | Synapse PACS | FUJIFILM Corporation | LLZ | Class II | |
| K183628 | Arthrex TensionLoc System | Arthrex GmbH | HWC | Class II | |
| K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | GXY | Class II | |
| K182947 | Dental Pain Eraser | Synapse Dental | LWM | Unclassified |