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 |
|---|---|---|---|---|---|
| K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corp. | FDA | Class II | |
| K080661 | Models TENS 7000, Ems 7500 and Twin Stim | Koalaty Products, Inc. | IPF | Class II | |
| K080495 | Suresigns Vm Series Patient Monitor, Models Vm4, Vm6, Vm8, Vm3 and Vs3 | Philips North America LLC | MHX | Class II | |
| K080302 | Cayman Buttress Plate System | K2M, Inc | KWQ | Class II | |
| K080157 | Dash 2500 Patient Monitor | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K073705 | Model Tw Sb, Scalp Vein Set; Model Tw Lb, Sterile Hypodermic Needle | Shandong Qiaopai Group Co., Ltd. | FMI | Class II | |
| K073674 | Bone Fixation Wire (Kirschner Wire) | Whiteside Biomechanics, Inc. | HTY | Class II | |
| K073502 | Vertebron Vbr System | Vertebron, Inc. | MQP | Class II | |
| K073255 | Xps 3000 System | Medtronic Xomed, Inc. | ERL | Class II | |
| K070184 | Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing Abutment | Ospol AB | DZE | Class II | |
| K080680 | Quill Self-Retaining System (Srs) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | NEW | Class II | |
| K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K080508 | Mandrel Guidewires or M-Wire | Lake Region Medical | OCY | Class II | |
| K080051 | Virtual Ports Endoclear System | Virtual Ports Ltd | GCJ | Class II | |
| K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | FTM | Class II | |
| K073346 | Ziehm Vision 2 | Ziehm Imaging GmbH | JAK | Class II | |
| K072739 | Jierui Syringes and Needles | ShanDong WeiGao Group Medical Polymer Co., Ltd | MEG | Class II | |
| K072406 | Non-Sterile, Powder Free, Pink Latex Examination Gloves with Cherry Flavour and Protein Labeling Claims (50 Ug or Less) | Sgmp Co., Ltd. | LYY | Class I | |
| K072369 | Evolution Blood Glucose Monitoring System | HMD Biomedical, Inc. | NBW | Class II | |
| K063684 | Cobas Lithium | Roche Diagnostics GmbH | NDW | Class II | |
| K080563 | Runthrough Ns Extension Wire | Terumo Medical Corp. | DQX | Class II | |
| K080518 | Pioneer Surgical Technology Quantum Spinal System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K080504 | Pioneer Lowtop Spinal Rod System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K080482 | Arthrocare Irrigation Pump, Model Sip001-00, Sip001-01 | ArthroCare Corporation | GEI | Class II | |
| K080457 | Color Lcd Monitor, Model Radiforce Rx211 | Eizo Nanao Corporation | LLZ | Class II | |
| K080204 | Vanguard Knee System Titanium Femoral Components | Zimmer GmbH | JWH | Class II | |
| K080154 | Acuity Universal Cutter | Cardiac Pacemakers, Inc. | DQY | Class II | |
| K080109 | Synthes (USA) Modular Blade Plate System | Synthes (USA) Products LLC | KTW | Class II | |
| K073653 | Sensititre 18 - 24 Hour Susceptibility Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K073652 | Nd Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle | Nakamura Magnifier Co., Ltd. | EFB | Class I | |
| K073638 | Swift Lt | ResMed Corp | BZD | Class II | |
| K073637 | Parallel-Sided Extensively Coated Femoral Stems | Biomet Manufacturing Corp | KWA | Class III | |
| K073624 | Modular Foot System | TORNIER Inc. | HRS | Class II | |
| K073363 | Thermostat 900 Administration Set, Model Ash 100, 200 and 300 | Paladin Biomedical Corporation | LGZ | Class II | |
| K073240 | Pss System | Spinal USA | MNI | Class II | |
| K073227 | Slimmanager Body Composition Analyzer, Models N40 and Sm-300 | Aiia Communication, Inc. | MNW | Class II | |
| K072723 | Respironics Golox | Respironics, Inc. | BYJ | Class II | |
| K072411 | Aap Bone Plates and Screw Implants | AAP Implantate AG | HRS | Class II | |
| K072116 | Savannah Lumbar Percutaneous Stabilization System | Neurospine Innovations and Solutions | NKB | Class II | |
| K071694 | Coopdech Endobronchial Blocker Tube, Models Bbt-A30xxx, Bbt-B30xxx | Daiken Medical Co, Ltd. | CBI | Class II | |
| K071468 | Clarivein Catheter | Vascular Insights, LLC | KRA | Class II | |
| K070855 | Sleep Quality | Dynadx Corporation | MNR | Class II | |
| K080667 | Variax Distal Radius Torx Screws | Howmedica Osteonics Corp | HRS | Class II | |
| K080291 | Intuitive Surgical Da Vinci Endoscopic Instruments and Control System and Endowrist Stabilizer | Intuitive Surgical, Inc. | NAY | Class II | |
| K080166 | Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K080025 | Led.l, Led.m, Led.g, Led.b | Guilin Woodpecker Medical Instrument Co., Ltd | EBZ | Class II | |
| K073718 | Medline Gastrostomy Tube | MEDLINE INDUSTRIES, LP - Northfield | KGC | Class II | |
| K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | LLZ | Class II | |
| K073698 | Secure | Parkell, Inc. | EMA | Class II | |
| K073635 | Sbi Sr Mtp Toe Implant | Small Bone Innovations, Inc. | KWD | Class II |