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 |
|---|---|---|---|---|---|
| K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint | Art Optical Contact Lens, Inc. | LPL | Class II | |
| K073500 | Active Anterior Cervical Plate System | Sanacor | KWQ | Class II | |
| K070888 | Combi 8 Max | Cec Electronica S.r.l. | IPF | Class II | |
| K053310 | Vascon Roamer Microcatheter | Vascon, LLC | KRA | Class II | |
| K081676 | Sonoace X6 Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II | |
| K081609 | Clever Chek and Audiochek Blood Glucose Monitoring Systems, Model Td-4237 | Taidoc Technology Corporation | CGA | Class II | |
| K081597 | Modification to Vertebron Pss Pedicle Screw System | Vertebron, Inc. | MNI | Class II | |
| K081565 | Integre Pro, Model L2ry | Ellex Medical Pty Ltd | HQF | Class II | |
| K081501 | Solitaire Anterior Spinal System | Highridge Medical, LLC | OVD | Class II | |
| K081383 | Reliance Vbs System | Reliance Medical Systems, LLC | MQP | Class II | |
| K081300 | Dimension Vista Hdlc Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | JHM | Class I | |
| K081125 | Wrist Pulse Oximeter Md300w | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K080991 | Depuy Asr Xl Modular Acetabular Cup System | Depuy Orthopaedics Inc. | KWA | Class III | |
| K080971 | Spinesmith Cimplicity Spinal System | Spine Smith Partners L.P. | MQP | Class II | |
| K080822 | Vu Apod Intervertabral Body Fusion Device | Theken Companies LLC | OVD | Class II | |
| K080319 | Kd-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K073303 | Norian Drillable | Synthes (USA) Products LLC | OIS | Class II | |
| K072678 | Laguna Size 8 Pedicle Screw | Allez Spine, LLC | NKB | Class II | |
| K071668 | Orthobiom Spinal System | Paradigm Spine GmbH | MNI | Class II | |
| K071446 | Electrode Array Cap | Electrode Arrays | GXY | Class II | |
| K071074 | Mykres Spinal System | Showa Ika Kohgyo Co., Ltd. | MNI | Class II | |
| K081637 | Laser Imager Drypro Model 873 | Konica Minolta Medical & Graphic, Inc. | LMC | Class II | |
| K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | EIH | Class II | |
| K081205 | Synthes (USA) 5.0Mm/7.3mm Crimp Positioning Pins | Synthes (USA) Products LLC | JDQ | Class II | |
| K080974 | Tls Fixation System | Fournitures Hospitalieres Industrie | HWC | Class II | |
| K080916 | Capillarys Urine | Sebia, Inc. | JKM | Class II | |
| K080915 | Fraxel Re:pair (Fraxel III Sr) Laser System and Accessories | Reliant Technologies, Inc. | GEX | Class II | |
| K080813 | Pressurewire Certus, Certus (300Cm), Aeris, Aeris (300Cm), Receiver | Radi Medical Systems AB | DXO | Class II | |
| K080695 | Mobile i.v. Systems 10,20,60 | Northwind Technologies, Corp. | FPA | Class II | |
| K072968 | Stressgard Nightguard | Totalgard Corporation | OBR | Unclassified | |
| K072901 | Amdl-Elisa Dr-70 (Fdp) Immunoassay, Model Dr2101 | Amdl, Inc. | NTY | Class II | |
| K081620 | Modification to Depuy Delta Xtend Reverse Shoulder System | Depuy Orthopaedics Inc. | KWS | Class II | |
| K081564 | Creaspine Supstance Vertebral Body Replacement System Line Extension | Creaspine | MQP | Class II | |
| K081411 | Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | JGS | Class II | |
| K081219 | Apollo Mini Ipl System | Sandstone Medical Technologies, LLC | GEX | Class II | |
| K081027 | Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile) | Kimberly-Clark Corporation | LZA | Class I | |
| K080657 | Neb-90 Large Volume Medication Nebulizer | Medi Nuclear Corp., Inc. | CAF | Class II | |
| K080537 | L-Varlock | Kiscomedica S.A. | MAX | Class II | |
| K080379 | Micrus Microcoil System, Deltapaq 10 Stretch Resistant | Micrus Endovascular Corporation | HCG | Class II | |
| K080100 | Watchhaler | Activaero America, Inc. | NVP | Class II | |
| K080073 | S-Test Creatinine (Cre) | Alfa Wassermann | JFY | Class II | |
| K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | DXX | Class II | |
| K072854 | Diachex Basic Blood Glucose Monitoring System, Diachex Superb Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K081665 | Millenium II | Next Mobility, LLC | IOR | Class I | |
| K081573 | Medtronic Export Ap Catheter | Medtronic, Inc. | DXE | Class II | |
| K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and Unscented | Procter & Gamble Co. | HIL | Class II | |
| K081542 | Modification to Entellus Medical Rs-Series System | Entellus Medical, Inc. | LRC | Class I | |
| K081473 | Hero, Version 2.0 | Medical Predictive Science Corp. | DPS | Class II | |
| K081243 | Biomet Phoenix Ankle Nail System | Biomet Trauma | HSB | Class II | |
| K081049 | Flexcath Steerable Sheath & Dilator, Models 3Fc10, 3Fc12 | Medtronic CryoCath LP | DRA | Class II |