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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd | LNH | Class II | |
| K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | OMP | Class II | |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline | Jk-Holding GmbH | LEJ | Class II | |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Organogenesis, Inc. | KGN | Unclassified | |
| K220298 | CerroZone Mobile | Cerrozone | FRF | Class II | |
| K220248 | Home use hair removal device | Shenzhen Mareal Tech Co., Ltd | OHT | Class II | |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific Inc. | QTF | Class II | |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | EOB | Class II | |
| K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Inc | NKG | Class II | |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, LLC | MNT | Class II | |
| K213488 | Bladder Scanner, Model Name:M5 | Suzhou Peaksonic Medical Technology Co., Ltd. | IYO | Class II | |
| K213385 | Gem | Obsidio Inc | KRD | Class II | |
| K213315 | CROSSLEAD Peripheral Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Argon Medical Devices, Inc | KNW | Class II | |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | LPH | Class II | |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton Dickinson & Co | BSP | Class II | |
| K203134 | Hanger Cranial Band 3D | Symbion Logistics, LLC | MVA | Class II | |
| K221750 | CPS AIM Universal II Slittable Inner Catheter | Abbott Medical | DQY | Class II | |
| K221571 | InMode Multi-system | Inmode Ltd. | GEX | Class II | |
| K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | Aegis Spine, Inc. | OUR | Class II | |
| K220651 | Wrist Type Blood Pressure Monitor | Shenzhen Jamr Medical Technology Co., Ltd. | DXN | Class II | |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | LOX | Class II | |
| K220378 | Sparta 3-Ply Surgical Disposable Face Mask | Sparta East, LLC | FXX | Class II | |
| K213949 | VASSALLO GT 018 Floppy | Filmecc Co., Ltd. | DQX | Class II | |
| K213913 | leva Pelvic Health System | Renovia, Inc. | HIR | Class II | |
| K213582 | Epicardial Access System | Baylis Medical Co., Inc. | DYB | Class II | |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | Blue Sky Bio, LLC | DZE | Class II | |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech Inc. | LCX | Class II | |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | CHH | Class I | |
| K221714 | Flat Panel Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K221611 | 780 nm L11 LED Light Source with AIM | Stryker Corp. | OWN | Class II | |
| K221312 | Diode Laser Hair Removal Device | Guangzhou Chuang Zao Mei Technology Co., Ltd. | GEX | Class II | |
| K221286 | Clarox | Vsi Co., Ltd. | EHD | Class II | |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K220937 | Arthrex Mini Fragment System | Arthrex GmbH | HRS | Class II | |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | MOF | Class II | |
| K220834 | Powder Free Nitrile Examination Glove | Daxwell, LLC | LZA | Class I | |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | PDU | Class II | |
| K220432 | ARTIS icono (VE21) System | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical Ltd | LIT | Class II | |
| K220409 | ARTIS pheno (VE21) System | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K220289 | FridaMom Anti-Nausea Bands | FridaBaby LLC | MVV | Unclassified | |
| K220017 | Coloring Liquid | Dongguan Xiangtong Co., Ltd. | EIH | Class II | |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | DQD | Class II | |
| K213231 | Kerecis Silicone | Kerecis Limited | KGN | Unclassified | |
| K211016 | Powered Breast Pump (Models 7V and 7X) | Haenim CO.,LTD. | HGX | Class II |