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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K240453 | ReBOSSIS | Orthorebirth Co Ltd | MQV | Class II | |
| K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | ITI | Class II | |
| K233738 | Overjet Caries Assist-Pediatric | Overjet | MYN | Class II | |
| K231288 | Vyvo | Vyvo Technology Corp.(Vt) | DQA | Class II | |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company Ltd. | NVK | Class II | |
| K240277 | MiroDry Wound Matrix | Reprise Biomedical, Inc. | KGN | Unclassified | |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K240023 | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | FLL | Class II | |
| K233862 | Nuna Lux (Nunl528) | Premier North America, Inc | OHS | Class II | |
| K233410 | LIAISON PLEX Respiratory Flex Assay | Luminex Corporation | QOF | Class II | |
| K233095 | S21 OTC Transcutaneous Electrical Nerve Stimulator | Micro Current Technology, Inc. | NUH | Class II | |
| K233030 | BoneMRI | Mriguidance B.V. | QIH | Class II | |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corp. | NFJ | Class II | |
| K232791 | Access Intact PTH | Siemens Healthcare Diagnostics Inc. | CEW | Class II | |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | MUD | Class II | |
| K232328 | Insignis™ Syringe Infusion System | Innovative Health Sciences | FPA | Class II | |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research & Development Corp. | LDR | Class II | |
| K232040 | Gynatrof | Tyros Biopharma Inc. | NUC | Class II | |
| K231915 | Zfx Abutments | Zfx GmbH - A Company of Zimvie | NHA | Class II | |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | CBK | Class II | |
| K231690 | iCAS-LV | Highrad, Ltd. | QIH | Class II | |
| K231648 | Muscle Stimulator | Shenzhen Yiran Intelligent Co., Ltd | NUH | Class II | |
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves | Anhui Intco Medical Products Co., Ltd. | LZA | Class I | |
| K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | KWD | Class II | |
| K240257 | Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit | BD | DTK | Class II | |
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | OKO | Class II | |
| K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | KWQ | Class II | |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | NDN | Class II | |
| K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K231683 | inHEART Models | Inheart, SAS | QIH | Class II | |
| K230837 | PlazMagik | Agnes Medical Co.,Ltd | GEI | Class II | |
| K233830 | OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA Inc | GEI | Class II | |
| K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | NVK | Class II | |
| K232613 | CT Cardiomegaly | Innolitics, LLC | QIH | Class II | |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc. | PDU | Class II | |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co.,Ltd. | EIA | Class I | |
| DEN230024 | Technozym ADAMTS13 Activity | Technoclone Herstellung von Diagnostika und Arzneimitteln GM | SAC | Class II | |
| K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | OUR | Class II | |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | Maquet Cardiovascular LLC | GEI | Class II | |
| K233623 | Praxiject™ SP 0.9% NaCl | Medxl, Inc. | NGT | Class II | |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | KLW | Class II | |
| K232607 | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM | Solco Biomedical Copany India Private Limited | NKB | Class II | |
| K232522 | ARK Levetiracetam II Assay | Ark Diagnostics Inc | ORI | Class II | |
| K222400 | Coresculpt & Magsculpt | K1Med Co., Ltd. | NGX | Class II | |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K233675 | FMS VUE™ Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | HRX | Class II |