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 |
|---|---|---|---|---|---|
| K241982 | DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies, Inc. | QIH | Class II | |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| DEN240031 | Prapela SVS hospital bassinet pad (model P01) | Prapela, Inc. | QVY | Class II | |
| K250658 | SureFine Pen Needle | Shina Med Corporation | FMI | Class II | |
| K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | QLY | Class II | |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO, Ltd. | MAI | Class II | |
| K243514 | Salvo® Robotic Navigation Instruments | Spine Wave Inc | OLO | Class II | |
| K243305 | Masimo W1 | Masimo Corporation | DPS | Class II | |
| K243298 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | Carbon (Shenzhen) Medical Device Co., Ltd. | IYN | Class II | |
| K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | QIH | Class II | |
| K242358 | Powered wheelchair (mobility robot) (M4, M4U) | Xsto Co., Ltd. | ITI | Class II | |
| K240615 | Leos Laser and Endoscopy System | Becton Dickinson & Co | HQF | Class II | |
| K250930 | twiist system | Deka Research & Development Corp. | QFG | Class II | |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | LOD | Class II | |
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | QNQ | Class II | |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell Limited | JXI | Class II | |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | OLO | Class II | |
| K242460 | Progenix Select Stim | Progenix, LLC | NUH | Class II | |
| K242117 | LifeShield Infusion Safety Software Suite | Abbott Medical | PHC | Class II | |
| K242115 | Plum Duo™ Precision IV Pump | Abbott Medical | FRN | Class II | |
| K242114 | Plum Solo™ Precision IV Pump | Abbott Medical | FRN | Class II | |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies | JXI | Class II | |
| K242067 | Visera Elite III Video System Center Olympus Otv-S700; Visera Elite III LED Light Source Olympus Cll-S700; 4K Camera Head Olympus Ch-S700-Xz-Ea | Olympus Corporations of the Americas | FET | Class II | |
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | HDR | Class II | |
| K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | QIH | Class II | |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | Orthopediatrics Corp | HSB | Class II | |
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn Bhd | LZA | Class I | |
| K250189 | AdvaTx | AdvaLight ApS | GEX | Class II | |
| K250018 | Medical Diode Laser Systems (THEIA808) | Gigaalaser Company Ltd. | GEX | Class II | |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular | MOF | Class II | |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics, Ltd. | NFO | Class II | |
| K242925 | MR Contour DL | GE Healthcare | QKB | Class II | |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico, S.A. de C.V. | HEB | Class II | |
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | EGJ | Class II | |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd | EBI | Class II | |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | MUM | Class II | |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | KTI | Class II | |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge to Life Ltd | KDN | Class II | |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IYN | Class II | |
| K242166 | TribusConnect | Tribusmed Beheer BV | QIH | Class II | |
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering Ltd. | GZL | Class II | |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | GYC | Class II | |
| K250596 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II |