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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K050866 | Centrion 500 C-Arm System | Osteosys Co.,Ltd | JAA | Class II | |
| K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, Gp Temperature Probe, Adult, Resuable | GE Healthcare | FLL | Class II | |
| K050752 | Aesculap Orthopilot 2 Tha V 2.0 | Aesculap Inc | HAW | Class II | |
| K050683 | Synthes (USA) 3.5Mm Conical Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K050543 | Nexus Detachable Coil System | Medtronic, Inc. | HCG | Class II | |
| K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control Lt, Liquichek Cardiac Markers Plus | Bio-Rad | JJY | Class I | |
| K050508 | Hvo, Inc., Disposable Non-Sterile Surgical Drapes | Haywood Vocational Opportunities Inc. | KKX | Class II | |
| K050340 | Micromedics Sphenoid Sinus Stent | Micromedics, Inc. | KAM | Class I | |
| K050324 | Infpump Infiltration Pump | Carolina Medical, Inc. | FRN | Class II | |
| K050188 | Epiguard | Episafe Medical Devices, Ltd. | JXL | Class II | |
| K050177 | Colactive Collagen Wound Dressing | Covalontechnologies, Inc. | KGN | Unclassified | |
| K043474 | Accu-Chek Aviva System | Roche Diagnostics GmbH | LFR | Class II | |
| K042767 | Datapro Clinical Chelistry Analyzer | Thermo Electron Oy | CFR | Class II | |
| K041826 | Ekos Ultrasound Infusion System | Ekos Corp. | NUI | Class II | |
| K041554 | Aip Intense Pulsed Light System | Aesthera Corporation | GEX | Class II | |
| K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | LXT | Class II | |
| K050815 | Xact.cardiac & Xpress.cardiac | Ultraspect, Ltd. | KPS | Class II | |
| K050719 | Abx Pentra Dx 120: Option Sps Evolution | Horiba Abx | GKZ | Class II | |
| K050708 | Lerado, Avanticare Mechanical Wheelchair, Mr-9000 | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | |
| K050646 | Synthes (USA) 3.5/4.5Mm Lcp Medial Proximal Tibia Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K050625 | Varelisa Recombi Ana Profile, Model 18496 | Sweden Diagnostics (Germany) GmbH | LJM | Class II | |
| K050619 | 20.8-Inch (53Cm) Color Lcd Monitor, Models Cdl2112a, Ccl350i & Dv3mc-Hb | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050544 | Hemosil D-Dimer Hs | Instrumentation Laboratory Co. | DAP | Class II | |
| K050533 | Eclipse Latex Powder Free Sterile Surgeon's Glove | Regent Medical Americas, LLC | KGO | Class I | |
| K050487 | Quantia La(a) | Biokit, S.A. | DFC | Class II | |
| K050462 | Sbi Hand Fixation System (Tm) | Small Bone Innovations, Inc. | HRS | Class II | |
| K050256 | Apple Medical/ob Mobius Elastic Retractor | CooperSurgical, Inc. | GAD | Class I | |
| K050194 | Axon Systems Subdermal Needle Electrodes | Axon Systems, Inc. | GXZ | Class II | |
| K050157 | Maxsight (Polymacon) Sport-Tinted Contact Lens | Bausch & Lomb Incorporated | LPL | Class II | |
| K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | DPS | Class II | |
| K050387 | Roche Diagnostics Elecsys Precicontrol Tumor | Roche Diagnostics GmbH | JJY | Class I | |
| K043519 | Ariol Her-2/Neu Fish | Applied Imaging Corp. | NTH | Class II | |
| K043231 | Proof Positive Electronic Pregnancy Test | Mizuho USA, Inc. | LCX | Class II | |
| K042526 | Drape, Surgical, X-Ray Element, Models Non Sterile 6120-00, Sterile 704-B, Non Sterile 6124-00X, Sterile 704-Bx | Medical Action Industries, Inc. 306 | KKX | Class II | |
| K050880 | Dyract Extra Restorative | Dentsply Intl. | EBF | Class II | |
| K050777 | Proforma HF 4.5 Cannula, Model 050906, 050907 | Conmedcorp | FGE | Class II | |
| K050762 | Philips Intellivue Patient Monitor, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70 and Mp90 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K050712 | 4.5.* 6.0Mm Dental Implant and 6.0*6.0 Mm Dental Implant | Bicon, LLC | DZE | Class II | |
| K050617 | 21.3-Inch (54Cm) Monochrome Lcd Monitor, Models Mdl2109a, Me251i & Dv2mm-Hb | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050578 | Cook Ireland Duette Multi-Band Mucosectomy Device | Cook Ireland Ltd. | KNS | Class II | |
| K050423 | Omni Modular, Omni C and Omni S Analyzer (Ph Electrode) | Roche Diagnostics GmbH | CHL | Class II | |
| K043495 | Babypac | Smiths Medical International Ltd., Luton | BTL | Class II | |
| K043228 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (Bnp) Assays | Medrad, Inc. | NBC | Class II | |
| K043143 | Safepico | Radiometer Medical ApS | JKA | Class II | |
| K042917 | Stat Medical Pen Needle | Emergogroup, Inc. | FMI | Class II | |
| K042116 | Sterrad Nx Sterilizer | Advanced Sterilization Products | MLR | Class II | |
| K050810 | Agfa Cr50.0 | Agfa Corp. | MQB | Class II | |
| K050792 | Landlex, Model S300x | Cycling and Health Tech. Industry R&D Center | INI | Class II | |
| K050772 | Navigus Reusable Passive Probe, Model Sp-2000 | Image-Guided Neurologics, Inc. | HAW | Class II | |
| K050751 | Impax Orthopaedic Workstation, Model Impax Es 5.X | Agfa Corp. | LLZ | Class II |