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 |
|---|---|---|---|---|---|
| K253590 | Millipede System | Perfuze | NRY | Class II | |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | GXR | Class II | |
| K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc | PGW | Class II | |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | DZE | Class II | |
| K252433 | Sonio Detect (v3) | Sonio | IYN | Class II | |
| K252282 | SurgiCount+ System | Stryker Corp. | PBZ | Class II | |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | MOF | Class II | |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Technomed Europe | IKT | Class II | |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | Abbott Medical | DQY | Class II | |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | |
| K260455 | New Wave System | Zeto, Inc. | GWQ | Class II | |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd | BTA | Class II | |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | JAK | Class II | |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging Ltd | LNH | Class II | |
| K254059 | Access anti-HBc IgM | Siemens Healthcare Diagnostics Inc. | SEI | Class II | |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | Gie Medical | FGE | Class II | |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing LLC | DXF | Class II | |
| K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | GXP | Class II | |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc | ONO | Class II | |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | PBX | Class II | |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | MTD | Class II | |
| K253111 | Aeka Imaging | Good Methods Global Inc. | LLZ | Class II | |
| K252923 | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | |||
| K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | PCU | Class II | |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | |
| K252249 | Extremity CT Imaging System | Mars Bioimaging, Ltd. | JAK | Class II | |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton Dickinson & Co | JKA | Class II | |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | FRO | Unclassified | |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | QYT | Class II | |
| K251848 | Pentacam® Cornea OCT | Oculus Optikgerate GmbH | MXK | Class II | |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | EZD | Class II | |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs S.r.l. | GXY | Class II | |
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co. KG | FWP | Class II | |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | KTI | Class II | |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing MIJO Technology Co., Ltd | INI | Class II | |
| K253743 | MiniMed Flex pump | Medtronic, Inc. | QFG | Class II | |
| K253734 | Taurus Clip | Taurus Endoscopy, Inc | PKL | Class II | |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | NGX | Class II | |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer GmbH | HSB | Class II | |
| K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | QKA | Class II | |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical Inc. | NRY | Class II | |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty Limited | JDI | Class II | |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | HGX | Class II | |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | HRX | Class II | |
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical Inc | DTR | Class II | |
| K252401 | implaFit® short stems | implantcast GmbH | LZO | Class II | |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co Ltd | EHD | Class II | |
| K252089 | Tyto Stethoscope (G3) | Tyto Care Inc. | DQD | Class II |