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 |
|---|---|---|---|---|---|
| K252016 | Arthrex Humeral Nails | Arthrex GmbH | HSB | Class II | |
| K252005 | Livi Device | Liviwell Inc | HEB | Class II | |
| K251980 | ClaveQS™ Bag | Abbott Medical | KPE | Class II | |
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) | Hangzhou Tappa Medical Technology Co., Ltd. | CBI | Class II | |
| K251937 | nordicAudio (1.0) | NordicNeuroLab AS | LNH | Class II | |
| K260537 | Willow 24 Guidewire | Arbor Endovascular | MOF | Class II | |
| K260533 | Elisio™-H | Nipro Medical Corporation | KDI | Class II | |
| K260532 | Derma-Gide | Geistlich Pharma AG | KGN | Unclassified | |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | QKB | Class II | |
| K260448 | CastleLoc Pectus Bar System | L&K Biomed Co.,Ltd. | HRS | Class II | |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. Shine Optical Co., Ltd. | LPL | Class II | |
| K254112 | Dia-X Sil Bite | Diadent Group International | ELW | Class II | |
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan Phomed Technology Co., Ltd. | ILY | Class II | |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | DQX | Class II | |
| K253432 | DiversiVy™ Facet Screw System | VY Spine, LLC | MRW | Unclassified | |
| K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | FBN | Class II | |
| K252101 | Jwg-1 | Yamaha Motor Co Ltd | ITI | Class II | |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | LBH | Class II | |
| K260188 | LimFlow Vector | LimFlow Inc. | MGZ | Class II | |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | Medshape, Inc. | HWC | Class II | |
| K253834 | Visuref 600 | Carl Zeiss Vision GmbH | HJO | Class II | |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | FMI | Class II | |
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated Instruments | Mirus, LLC | OLO | Class II | |
| K253012 | AlignRT Plus (8.0) | Vision Rt Inc | IYE | Class II | |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | HSB | Class II | |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | MUJ | Class II | |
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | FXX | Class II | |
| K260632 | Laser Thermal Therapy Kit | Elesta SpA | GEX | Class II | |
| K260546 | Q Pedicle Instruments | K2M, Inc | OLO | Class II | |
| K260390 | Super Upper Limbs Versalock Plating System | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K254167 | MDx-Chex for BCY | Streck LLC | PMN | Class II | |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | HRS | Class II | |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28 | MBI | Class II | |
| K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | Serim Research Corp. | FKJ | Class II | |
| K253750 | Btl-785Neh | BTL Industries, Inc | GEI | Class II | |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | QIH | Class II | |
| K253587 | Cala kIQ Plus | Cala Health, Inc. | QBC | Class II | |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard Inc | GEX | Class II | |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | INI | Class II | |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc | MNS | Class II | |
| K251926 | enCore Impression Material | Encore Guards | SHI | Class II | |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care Inc. | SHL | Class II | |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHS | Class II | |
| K254176 | Sinefix | Baat Medical Products B.V. | MBI | Class II | |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | OHS | Class II | |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics Inc. | NKG | Class II | |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | QIH | Class II | |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | HRS | Class II | |
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | DTZ | Class II | |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific LLC | DJC | Class II |