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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | FMG | Class II | |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | LHI | Class II | |
| K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device | Becton Dickinson & Co | JKA | Class II | |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Gme German Medical Engineering GmbH | GEX | Class II | |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | HSX | Class II | |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | Thermo Fisher Scientific Oy | NGZ | Class II | |
| K221129 | CloudTMS for OCD | Teleemg, LLC | QCI | Class II | |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular | MOF | Class II | |
| K213744 | Avoset Infusion Pump System | Eitan Medical Ltd | FRN | Class II | |
| K230363 | CPS Locator 3D Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Co., Ltd. | PEK | Class II | |
| K223693 | Electric breast pump (model: M5) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | ILY | Class II | |
| K223514 | Spectral Bone Marrow | GE Healthcare | JAK | Class II | |
| K223432 | Vassallo GT 018 Hybrid | Filmecc Co., Ltd. | DQX | Class II | |
| K222875 | Powered Muscle Stimulator (Model name:MagGraver F200) | Nanjing Vishee Medical Technology Co., Ltd. | NGX | Class II | |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | FGE | Class II | |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | bioMerieux, Inc. | LON | Class II | |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | |
| K221930 | CEREGLIDE 71 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia SAS | HRX | Class II | |
| K221816 | Wesper Lab | Wesper, Inc. | MNR | Class II | |
| K221706 | AccuContour | Manteia Technologies Co.,Ltd. | QKB | Class II | |
| K221700 | AutoPulse NXT Resuscitation System | ZOLL Circulation, Inc. | DRM | Class II | |
| K221373 | Essenz HLM | LivaNova Deutschland GmbH | DTQ | Class II | |
| K221301 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K230321 | Persona™ Personalized Knee System | Zimmer GmbH | JWH | Class II | |
| K230076 | Enhanced AURORA™ Medical Diode System, and related accessories | Psoria-Shield Inc | FTC | Class II | |
| K223742 | Dental Ceramic Blocks | Aidite (Qinhuangdao) Technology Co., Ltd | EBF | Class II | |
| K223688 | CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments | Medos International SARL | MAX | Class II | |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte Ltd | BZQ | Class II | |
| K222355 | PathKeeper System | Pathkeeper Surgical Ltd. | OLO | Class II | |
| K222136 | Cryo-Thermo Compression Device (FGK002) | Suzhou Microport Rehabtech (Group) Co., Ltd. | IRP | Class II | |
| K222098 | ManaSport+ | Manamed LLC | IMI | Class II | |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex GmbH | QHE | Class II | |
| K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops | Padm Medical, Inc. | FXX | Class II | |
| K220966 | Sinefix | Baat Medical Products B.V. | MBI | Class II | |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb Incorporated | LPL | Class II | |
| K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical Ltd | OMP | Class II | |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Ortho-Clinical Diagnostics, Inc. | QVF | Class II | |
| K230331 | Protrieve Sheath | Inari Medical, Inc. | QEW | Class II | |
| K230301 | Athena III Cervical Plate System | Medyssey USA | KWQ | Class II | |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | JAK | Class II | |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | FYA | Class II | |
| K223024 | MedCAD AccuPlan System | MedCAD | DZJ | Class II | |
| K222897 | Enlight 2100 | Timpel S.A. | QEB | Class II | |
| K222465 | Tyber Medical Anatomical Plating System | Tyber Medical | HRS | Class II | |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Boston Scientific Corporation | NEY | Class II |