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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K241608 | nordicMEDiVA | NordicNeuroLab AS | LLZ | Class II | |
| K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | Biosense Webster Inc | OBJ | Class II | |
| K241406 | Lavieen | WONTECH Co., Ltd. | GEX | Class II | |
| K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | LZU | Unclassified | |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | EMA | Class II | |
| K241154 | Electric Wheelchair (YFWB-63) | IF Health (Xiamen) Intelligent Technology Co.,Ltd | ITI | Class II | |
| K240927 | Access Thyroglobulin | Siemens Healthcare Diagnostics Inc. | MSW | Class II | |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical LLC | ODP | Class II | |
| K240892 | XSense Cryoablation System with Cryoprobes | Icecure Medical Ltd | GEH | Class II | |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | MHX | Class II | |
| K240215 | Blue 400; Blue 400 S | Carl Zeiss Meditec Inc | QFX | Class II | |
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment(guangzhou) Co., Ltd. | FIB | Class II | |
| K233823 | Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd | KNG | Class II | |
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp. | DQY | Class II | |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd | NEU | Class II | |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical Ltd | MCW | Class II | |
| K241542 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | FRC | Class II | |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | SleepNet Corporation | CBK | Class II | |
| K241509 | TENS&EMS units (SM9109A, SM9109B) | Plexus Yoga, LLC dba Chirp | NUH | Class II | |
| K241506 | Annabella Double Breast Pump (ADO-US23-1000) | Annabella Tech | HGX | Class II | |
| K241212 | MagnetOs Easypack Putty | Kuros Biosciences BV | MQV | Class II | |
| K240938 | The Optimotion™ Blue Plus Knee System | Optimotion Implants, LLC | MBH | Class II | |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc | FED | Class II | |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG | EBF | Class II | |
| K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | FRC | Class II | |
| K240564 | NuFACE® FIX+ | Carol Cole Company dba NuFACE | NFO | Class II | |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | LZO | Class II | |
| K240327 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc | JWH | Class II | |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | Edwards Lifesciences LLC | DYG | Class II | |
| K233762 | SteroScope® Sterilization Technology System | Ideate Medical | MLR | Class II | |
| K233398 | Faros Surgical System | Oertli Instrumente AG | HQC | Class II | |
| K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | PLA | Class II | |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | Cepheid | SBP | Class II | |
| DEN230055 | FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System | Balance Ophthalmics, Inc. | QQJ | Class II | |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. | DTK | Class II | |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote S.p.A. | LNH | Class II | |
| K240875 | Unity Knee PS-C Tibial Insert | Corin USA | JWH | Class II | |
| K234059 | Forma Medical Optimal Plating System | Forma Medical, Inc. | HRS | Class II | |
| K233840 | Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) | Zhuhai Dipu Medical Technology Co., Ltd. | GCJ | Class II | |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | IYO | Class II | |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating LLC | JOJ | Class II | |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America, Inc. | JAA | Class II | |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena GTX | MWI | Class II | |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi ve Ticaret A.S. | LHI | Class II | |
| K232829 | Versalock Rib and Sternum Plates System | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K222771 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd | QBD | Class II | |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K240824 | Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) | Ningxia Qiaoen Medical Technology Co., Ltd. | LZA | Class I | |
| K240582 | VEA Align; spineEOS | EOS imaging | QIH | Class II |