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 |
|---|---|---|---|---|---|
| K070519 | Prime Protection Powdered Vinyl Examination Gloves | Zhang Jia Gang Huayuan Plastic Co., Ltd. | LYZ | Class I | |
| K070300 | Expedium Sfx Cross Connector System | DePuy Spine, Inc. | KWP | Class II | |
| K070143 | Jms Planecta Stopcock | JMS North America Corp. | FMG | Class II | |
| K063542 | Wireless Temperature Monitor / Models St323c and St323f. | Mesure Technology Co., Ltd. | FLL | Class II | |
| K070734 | Modification to: Direct Enzymatic Hba1c Assay Kit, Model# Dz168a, Dz168a-Cal, Dz168a-Con | Diazyme Laboratories, Inc. | LCP | Class II | |
| K070641 | Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System, Model Td-3223 | Taidoc Technology Corporation | NBW | Class II | |
| K063720 | Vitros Immunodiagnostic Products Total B-Hcg II Reagent Pack, Calibrators, Range Verifiers | Ortho-Clinical Diagnostics, Inc. | DHA | Class II | |
| K062545 | Rmi Lcd Alcohol Detector | Resource Management International, LLC | DJZ | Class I | |
| K062261 | Foam Ring Port Protector | Inspired Ideas, Incorporated | OBK | Class II | |
| K061505 | Powered Nitrile Blue Examination Gloves | Liwe Trading | LZA | Class I | |
| K070818 | Medilogar4, Medilogar12 | Tom Medical Entwicklungs GmbH | DSH | Class II | |
| K070803 | Invivodental | Anatomage, Inc. | LLZ | Class II | |
| K070796 | Chili Pacs | Chili GmbH | LLZ | Class II | |
| K070792 | Qlab Quantification | Philips North America LLC | LLZ | Class II | |
| K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | HCG | Class II | |
| K070671 | Opus Smartstitch Suture Device | ArthroCare Corporation | OCW | Class II | |
| K070624 | Hyperq System | Biological Signal Processing, Ltd. | MWI | Class II | |
| K070218 | Vertiflex Octane Peek Vertebral Body Replacement (Peek Vbr) | Vertiflex (Tm), Incorporated | MQP | Class II | |
| K070166 | Strada Carotid Guiding Sheath | Abbott Medical | DYB | Class II | |
| K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | DQY | Class II | |
| K063872 | Kinesia | Cleveland Medical Devices, Inc. | GYD | Class II | |
| K063501 | Knightcontrol Remote Control, Model M-114700-US | Mallinckrodt Developpement France | BZD | Class II | |
| K062862 | Olympus Uric Acid Reagent, Model Osr6x98 | OLYMPUS Corporation of the Americas | KNK | Class I | |
| K061846 | Combi Scan100 | Analyticon Biotechnologies AG | JIL | Class II | |
| K061812 | Combi Scan 500 Urine Test Strip Analyzer, Model A93005 | Analyticon Biotechnologies AG | JIL | Class II | |
| K070738 | Sis Facial Cylinder, Sis Facial Implant | Cook Biotech, Inc. | FTM | Class II | |
| K070686 | Mini Lap Instruments | Mini Lap Technologies, Inc. | OCW | Class II | |
| K070680 | Cardiomems Endosure S2 14F Wireless Aaa Pressure Measurement System, Model# S2-2080 | Cardiomems, Inc. | NQH | Class II | |
| K070658 | Dental Digital Panoramic/3d Imaging System | E-Woo Technology | JAK | Class II | |
| K070657 | Getinge 633Hc Series Vacuum/gravity Steam Sterilizer | Getinge Sourcing, LLC | FLE | Class II | |
| K070523 | Modification to: Velscope | LED Dental Inc. | NXV | Class II | |
| K070505 | Krystal-X Wifi | Owandy Inc. | MUH | Class II | |
| K070390 | Fluoropro RF Digital Imaging System | Virtual Imaging, Inc. | JAA | Class II | |
| K070352 | Mini Lap Pediatric Instruments with Medusa Clamping System | Mini Lap Technologies, Inc. | OCW | Class II | |
| K070245 | Capsure Pedicle Screw System | Spine Wave Inc | MNI | Class II | |
| K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | QSY | Unclassified | |
| K063458 | 3M Tegaderm Chg Dressing | 3M Company | FRO | Unclassified | |
| K062284 | Ces Ultra | Neuro-Fitness LLC | QJQ | Class II | |
| K061479 | Argos | 3D Line Medical Systems S.r.l. | HAW | Class II | |
| K070659 | Biolucent Applicator Kit | Biolucent, Inc. | JAQ | Class II | |
| K070430 | Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets | Unomedical A/S | FPA | Class II | |
| K070221 | Fmp Metal/metal Acetabular Insert, 499-28,449-34, 499-38 | Encore Medical, LP | KWA | Class III | |
| K070182 | Zygoma Implant (Immediate Function) | Nobel Biocare AB | DZE | Class II | |
| K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | ONN | Class II | |
| K063848 | Powergroshong Picc Catheter | C.R. Bard Inc | LJS | Class II | |
| K063728 | Tnn-Du810 Non-Invasive Subdermal Therapy System | Alfa Tech Medical Systems, Ltd. | IMG | Class II | |
| K063565 | Quanta Lite Ss-a 52 Elisa | Inova Diagnostics, Inc. | OBE | Class II | |
| K063139 | Spinal Stabilizing Sphere System | Highridge Medical, LLC | NVR | Class III | |
| K062682 | Cvs Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | NUC | Class II | |
| K070274 | Echo Bi-Metric Press-Fit Stems | Biomet Manufacturing Corp | KWA | Class III |