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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | Immunalysis Corporation | DJR | Class II | |
| K151146 | N-Force Fixation System | Innovision, Inc. | HWC | Class II | |
| K151068 | SureLock W Suture Anchor | Cayenne Medical Inc. | MBI | Class II | |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | EIA | Class I | |
| K151038 | EPX-Series Mobile X-ray System | ECOTRON Co., Ltd. | IZL | Class II | |
| K150968 | TRU Dental Implant System | Sterngold Dental LLC | DZE | Class II | |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | DZE | Class II | |
| K150906 | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh | Ehicon, Inc. | FTL | Class II | |
| K150486 | Halo | J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB | Class II | |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | DPW | Class II | |
| K150344 | Dentis Dental Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K150295 | LOCATOR RTx | Zest Anchors LLC | NHA | Class II | |
| K143347 | Powder-Free Yellow Vinyl Patient Examination Gloves | Zibo Zhouheng Plastic Products Co., Ltd. | LYZ | Class I | |
| K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters | Boston Scientific Corporation | LIT | Class II | |
| K143120 | OrthoPulse | Biolux Research, Ltd. | PLH | Class II | |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | NIE | Class II | |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | B.Braun Medical, Inc. | FPA | Class II | |
| K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | Cook Incorporated | DYB | Class II | |
| K142726 | O Glide Personal Lubricant | Grafenberg Labs | NUC | Class II | |
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set, Rapidfret Oral Fluid Cocaine Control Set | Biophor Diagnostics, Inc. | DIO | Class II | |
| K141427 | Accumetrics,inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest | Accumetrics, Inc. | JOZ | Class II | |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt Urs-10 Strips | Teco Diagnostics | JIL | Class II | |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | DXX | Class II | |
| K151532 | KYPHON ELEMENT Inflatable Bone Tamp | Medtronic, Inc. | HRX | Class II | |
| K151314 | CinchLock Flex Knotless Suture Anchor | Pivot Medical | MBI | Class II | |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | IPF | Class II | |
| K150248 | ORL Video NasoPharyngo-Larngoscope | JEDMED Instrument Company | EQN | Class II | |
| K143735 | Digital Automatic Blood Pressure Monitor MD2300 | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K143383 | Q6 Edge EM | Pride Mobility Product Corporation | ITI | Class II | |
| K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device | Smith & Nephew, Inc. | OMP | Class II | |
| K142962 | PROTOCOL Incision Dressing | DeRoyal Industries, Inc. | FRO | Unclassified | |
| K141720 | iuStar300 Medical Ultrasound Diagnostic System | United Imaging Systems (Beijing) Co., Ltd. | IYN | Class II | |
| K140740 | Transonic Tissue Perfusion Monitor | Transonic Systems Inc | DPW | Class II | |
| K151676 | Retracta Detachable Embolization Coil | Cook Incorporated | KRD | Class II | |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | ELITechGroup Inc | CJY | Class II | |
| K151107 | CoSense ETCO Monitor | Capnia Inc | CCJ | Class II | |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | ETD | Class II | |
| K151020 | Rampart-T Interbody Fusion System | Spineology, Inc. | MAX | Class II | |
| K150875 | iFuse Implant System | SI-Bone, Inc. | OUR | Class II | |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | LXB | Class II | |
| K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | OAP | Class II | |
| K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products | EMA | Class II | |
| K150370 | Nutra Light Advanced | Nutra Luxe MD, LLC | OLP | Class II | |
| K143346 | Powder-Free White Vinyl Patient Examination Gloves | Zibo Changda Plastic Products Company, Limited | LYZ | Class I | |
| K143152 | TM-ABI system | LD Technology LLC | JOM | Class II | |
| K143143 | Pathway Elif | Custom Spine, Inc. | MAX | Class II | |
| K151858 | Caiman Seal and Cut Technology | Aesculap Inc | GEI | Class II | |
| K151094 | Mosaic Universal Composite | Ultradent Products Inc. | EBF | Class II | |
| K151035 | PulseRelief | Philips Consumer Lifestyle B.V. | NUH | Class II |