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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K180102 | Embozene Color-Advanced Microspheres | Boston Scientific Corporation | NOY | Class II | |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. | LIT | Class II | |
| K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | FMI | Class II | |
| K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments | Medacta International SA | PQC | Class II | |
| K172919 | EV-804 OTC Pain Relief TENS | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Guangzhou Xinbo Electronic Co., Ltd | GXY | Class II | |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | Itw Contamination Control Electronics | MLY | Unclassified | |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | EZN | Class II | |
| K172478 | TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. | GZJ | Class II | |
| K172477 | iSchemaView RAPID | Ischemaview, Inc. | LLZ | Class II | |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | Avita Corporation | FLL | Class II | |
| K172416 | Synermed Opiate Enzyme Immunoassay | Infrared Laboratory Systems, LLC (dba Synermed) | DJG | Class II | |
| K172365 | Panoramic Oxygen Mask (POM) | POM Medical, LLC | CCK | Class II | |
| K172306 | SuperSlyde Personal Lubricant | Icm Pharma Pte Ltd | NUC | Class II | |
| K172167 | Zenith Flex System | Inneuroco, Inc. | NRY | Class II | |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | FMZ | Class II | |
| K171720 | encevis | Ait Austrian Institute of Technology GmbH | OMB | Class II | |
| K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA Inc | NKG | Class II | |
| K180836 | Genistrong | Genicon, Inc. | GCJ | Class II | |
| K180081 | RAILWAY Sheathless Access System | Cordis US Corp. | DYB | Class II | |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | HSD | Class II | |
| K173661 | Wingman 35 Crossing Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K173615 | Stryker Universal Select Sterilization Tray System | Paragon Medical Inc. | KCT | Class II | |
| K173432 | ENZA-A Titanium ALIF | Camber Spine Technologies | OVD | Class II | |
| K172947 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | MAX | Class II | |
| K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K180914 | Aesculap Slim Clip Applier | Aesculap Inc | HCI | Class II | |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | DXC | Class II | |
| K180588 | FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device | Teleflex Medical | FMI | Class II | |
| K180458 | FOCUS Pedicle Screw System | Nvision Biomedical Technologies, Inc | NKB | Class II | |
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd | GEX | Class II | |
| K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc | MAX | Class II | |
| K173816 | Nm/ct 850, Nm/ct 860 | GE Healthcare | KPS | Class II | |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra Inc. | HCG | Class II | |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | FDF | Class II | |
| K172735 | WR19 System | Zeto, Inc. | GWQ | Class II | |
| K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S | Olympus Medical Systems Corp. | GEI | Class II | |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | KNS | Class II | |
| K180126 | Sozo | Impedimed, Inc. | OBH | Class II | |
| K180096 | GDT-1000 System | Acuvu, Inc. | HIH | Class II | |
| K173935 | Mediant Anterior Cervical Plating System | Intelligent Implant Systems, LLC | KWQ | Class II | |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | Phadia AB | DHB | Class II | |
| K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | DPS | Class II | |
| K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | FAD | Class II | |
| K180704 | SonoSite iViz Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K180699 | Voyant Open Fusion Device | Applied Medical Resources Corp | GEI | Class II |