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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K053509 | Acuband Acupressure Wrist Band Device | Acuband, Inc. | MVV | Unclassified | |
| K062259 | Iscience Surgical Fiberoptic Illuminator, Model Fi - 100 | Iscience Surgical Corporation | MPA | Class II | |
| K062066 | Omega 3 System | Howmedica Osteonics Corp | KTT | Class II | |
| K062004 | Modification to Quantum Vertebral Body Replacement | Quantum Orthopedics, Inc. | MQP | Class II | |
| K061999 | Dry Laser Imager, Drypro Model 832 | Konica Minolta Medical & Graphic, Inc. | LMC | Class II | |
| K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options | GE Healthcare | OWB | Class II | |
| K061752 | Spinal USA Vbr System | Spinal USA | MQP | Class II | |
| K061361 | Faxitron Digital Radiography System, Model Dx-50 | Faxitron X-Ray Corp. | MWP | Class II | |
| K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | NHI | Class II | |
| K061013 | Playtex Embrace Petite Breast Pump | Playtex Products, Inc. | HGX | Class II | |
| K060923 | Naviaid Bge Device, Model 21-001 | Smart Medical Systems Ltd. | FDA | Class II | |
| K060557 | Suresave Tm Self-Expandable Nitinol Stent and Precision Tm Delivery Catheter-Ss06120060 | Idev Technologies, Inc. | FGE | Class II | |
| K060423 | Cyan Dxd, Multitest Cd8/cd4/cd3, Cd3-Fitc, Cd3-Rpe, Cd3-Apc and Fluorospheres | Agilent Technologies, Inc. | GKZ | Class II | |
| K062073 | Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K061885 | Dimension Vista System Total Triiodothyronine Calibrator, Model Kc250 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K061760 | Arm Blood Pressure Monitor, Model Kp-7600 | K-Jump Health Co., Ltd. | DXN | Class II | |
| K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | FXX | Class II | |
| K061610 | Philips Model Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 and Mp90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K061483 | Vacuette Visio Plus Blood Collection Needles | Greiner Bio-One North America, Inc. | FMI | Class II | |
| K061468 | Refstar External Reference Patch | Biosense Webster Inc | DRF | Class II | |
| K061463 | Esophageal Mapping Catheter, Model D-1272-01-S | Biosense Webster Inc | DRF | Class II | |
| K061269 | Xltek Clean Signal Adhesive Electrodes | Excel Tech., Ltd. | GXY | Class II | |
| K060576 | Nellcor Oximax N-600X Pulse Oximeter | Medtronic, Inc. | DQA | Class II | |
| K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing Corp | MBH | Class II | |
| K062220 | Modification to Guarddog Occlusion System | Possis Medical, Inc. | MJN | Class II | |
| K062201 | Spiderx Embolic Protection Device | Medtronic, Inc. | NFA | Class II | |
| K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- Web05 Software | GE Healthcare | MSX | Class II | |
| K061978 | Ebi, L.p.'s Line Extension to the Array Spinal System | Ebi, LLC | MNI | Class II | |
| K061916 | Neuro II-Se, Models or-Mb-Dr and or-Dr | Imris, Inc. | LNH | Class II | |
| K061832 | Jostra Hlm Tubing Sets with Safeline Coating | MAQUET CARDIOPULMONARY GmbH | DWF | Class II | |
| K061750 | Dimension Vista System Lipid Calibrator, Model Kc220 | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K061707 | Heartstart Mrx, Invasive Pressure & Temperature Options | Philips North America LLC | MKJ | Class III | |
| K061579 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K061559 | Acon Urinalysis Reagent Strips | Acon Laboratories, Inc. | CDM | Class I | |
| K061521 | Triathlon Metal Backed Patella | Howmedica Osteonics Corp | MBH | Class II | |
| K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | Nobel Biocare AB | NHA | Class II | |
| K061451 | Ascension, Models Cmc-400,13,Cmc-400-20,Cmc-400-30,Cmc-400-40 | Ascension Orthopedics, Inc. | KYI | Class II | |
| K061332 | Filterwire Ez Embolic Protection System (2.25 Mm-3.5 Mm) | Boston Scientific Corporation | NFA | Class II | |
| K061176 | Straumann Dental Implants | Straumann USA, LLC | DZE | Class II | |
| K061099 | Breathx Nasal Pillow and Mask System, Model 011-0003 | Hoffman Laboratories, LLC | BZD | Class II | |
| K060978 | Coaguchek Xs System | Roche Diagnostics GmbH | GJS | Class II | |
| K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics GmbH | NBW | Class II | |
| K053519 | Safety Syringe | Wuxi Yushou Medical Applicances Co., Ltd. | MEG | Class II | |
| K062154 | Vital Connect 4.0 | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K061975 | Plasmaseal Open Forceps, Models 2103Pk and 91701Pk | Acmi Corporation | GEI | Class II | |
| K061867 | Bd Phoenix Automated Microbiology System-Cefazolin (Gn) 0.5-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K061855 | Neuroquant | Cortechs Labs, Inc. | LLZ | Class II | |
| K061789 | Lateral Plate System | NuVasive Inc | KWQ | Class II | |
| K061783 | Knee Fusion Nail | Smith & Nephew, Inc. | JDS | Class II | |
| K061425 | Purewrist Scissors, Model Pw1101-01;Purewrist Dissector, Model Pw1201-01;Purewrist Hook, Model Pw1301-01 | Cambridge Endoscopic Devices | GEI | Class II |