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 |
|---|---|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed, Ltd. | NDN | Class II | |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | IRP | Class II | |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co.,Ltd. | FRG | Class II | |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | QKB | Class II | |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International SA | LPH | Class II | |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | HCG | Class II | |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | GEI | Class II | |
| K251995 | Access anti-HAV IgM | Siemens Healthcare Diagnostics Inc. | LOL | Class II | |
| K251435 | InbellaIgnite RF System | Inbella Medical Inc. | GEI | Class II | |
| K251195 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | LNH | Class II | |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | KDI | Class II | |
| K251670 | MAC 7 Resting ECG Analysis System | GE Medical Systems Information Technologies, Inc. | DPS | Class II | |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | |
| K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | GEX | Class II | |
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products Inc | NEU | Class II | |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine | MAX | Class II | |
| K253738 | 3.0T Air 32Ch Hna | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co.,Ltd | OHS | Class II | |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OAP | Class II | |
| K253285 | Elitone for Men | Elidah | QAJ | Class II | |
| K253160 | Syntex Exam Gloves | Basic Medical Technology Inc. | LZA | Class I | |
| K252957 | Pneumo Dissector Hook | AB Medica SAS | GCJ | Class II | |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech Inc. | OLO | Class II | |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | FRO | Unclassified | |
| K251351 | AccuContour 4.0 | Manteia Technologies Co.,Ltd. | QKB | Class II | |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories, Limited | DJG | Class II | |
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | DSI | Class II | |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | QIH | Class II | |
| K253652 | Genie MAX Large Bore Introducer Sheath | CULTIV8 1, LLC | DYB | Class II | |
| K253498 | Pump In Style® Pro+ | Medela AG | HGX | Class II | |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Straumann USA, LLC | NHA | Class II | |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | NHA | Class II | |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | QIH | Class II | |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | DRG | Class II | |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | PML | Class II | |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.p.A. | PHX | Class II | |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | FLE | Class II | |
| K251511 | PhenoMATRIX | Copan WASP | PPU | Class II | |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | KGN | Unclassified | |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF | Class II | |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA Inc | NKG | Class II | |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical Inc. | QEW | Class II | |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex GmbH | HRS | Class II | |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K252369 | Boston Pico755 | Boston Aesthetics Inc | GEX | Class II | |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd | DQX | Class II | |
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | QFX | Class II | |
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | SHB | Class II | |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | DWF | Class II |