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 |
|---|---|---|---|---|---|
| K021393 | Preciset Dat Plus | Quantimetrix Corp. | DKB | Class II | |
| K021113 | Mammopath | Fischer Imaging Corp. | MWP | Class II | |
| K020991 | Syngo Mr 2002B | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K020966 | Rpi Replacement Heating Elements | Replacement Parts Industries, Inc. | FMT | Class II | |
| K020957 | Oracam | Video Dental Concepts, Inc. | EIA | Class I | |
| K020856 | Spatouch Photoepilation System | Radiancy (Israel), Ltd. | GEX | Class II | |
| K020853 | Nuvasive Mesh | NuVasive Inc | EZX | Class II | |
| K020753 | Deroyal Surgical, Umbilicup | Deroyal | KSR | Class II | |
| K020717 | Ebv V Vca Igm Elisa Kit Model# Ebm-200 | Pan Bio Pty., Ltd. | GNP | Class I | |
| K020707 | Ebv-Ebna Igg Elisa Kit, Model Ebg-100 | Pan Bio Pty., Ltd. | GNP | Class I | |
| K020706 | Ebv-Vca Igg Elisa Test, Model Ebg-100 | Pan Bio Pty., Ltd. | GNP | Class I | |
| K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | IYN | Class II | |
| K020603 | Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010 | Good Biotech Corp. | DCN | Class II | |
| K020588 | X-Image Digital X-Ray System | Escape Technology, Inc. | MUH | Class II | |
| K013022 | Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis | Sulzer Carbomedics, Inc. | DSY | Class II | |
| K021755 | Apex Medical Digital TENS Ts1211, Ts1212 | Apex Medical, Inc. | GZJ | Class II | |
| K021715 | Cemex Rx, Cemex Isoplastic & Cemex Xl | Exactech, Inc. | LOD | Class II | |
| K021575 | Obc-127 Breast Array Coil | Mri Devices Corp. | MOS | Class II | |
| K021570 | Hnc-127-Trio Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K021160 | Dermmatrix Surgical Mesh | Carbon Medical Technologies, Inc. | FTM | Class II | |
| K021109 | Esop Co-Cr Femoral Heads | Fournitures Hospitalieres | LPH | Class II | |
| K020884 | Excellite Light Cure Unit | Rolence Ent. Inc. | EBZ | Class II | |
| K020877 | Excellite Turbo Light Cure Unit | Rolence Ent. Inc. | EBZ | Class II | |
| K020874 | Ultra-Lite 5 Turbo Light Cure Unit | Rolence Ent. Inc. | EBZ | Class II | |
| K020872 | Synthes 3.5 Mm Broad Lc-Dcp Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K020835 | Ceralas D10-60 810Nm Diode Laser, Modelceralas Dio-60 | Biolitec, Inc. | GEX | Class II | |
| K020834 | Bd Introsyte Precision Introducer; Bd Introsyte-N Precision Introducer; Bd Introsyte Autoguard Shielded Introducer; Bd I | Becton Dickinson Infusion Therapy Systems Inc. | DYB | Class II | |
| K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | NUC | Class II | |
| K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | BWK | Unclassified | |
| K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | FTL | Class II | |
| K012969 | Double Springers Nonoxnol 9 Condom | MedTech Products, Inc. | LTZ | Class II | |
| K012701 | Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa) | Accumetrics, Inc. | JOZ | Class II | |
| K021673 | Total Hip Femoral Head - 12/14 Taper | Smith & Nephew, Inc. | LZO | Class II | |
| K021667 | Disposable Vinyl Synthetic Exam Gloves, Powder Free | Safehealth Medical Supply Corp. | LYZ | Class I | |
| K021561 | Dermagrip and Multiple Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim (50 Microgram O | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | |
| K021513 | Accu-Chek Advantage Module | Roche Diagnostics GmbH | NBW | Class II | |
| K021150 | Coulter Cellprep | Siemens Healthcare Diagnostics Inc. | GKH | Class I | |
| K021018 | Microscan Microstrep Plus Panel - Chloramphenicol | Dade Microscan, Inc. | JWY | Class II | |
| K020869 | First Check Home Drug Test for Mdma (Ecstasy) | Worldwide Medical Corp. | DKZ | Class II | |
| K020866 | Freestyle Tracker Diabetes Management System | Abbott Medical | NBW | Class II | |
| K020836 | Rabea Cement Restrictor | Signus Medical, LLC | JDK | Class II | |
| K020410 | Microscan Rapid/s Plus Gram-Negative Mic/combo Panels with Cephalothin (2-64 Ug/ml) | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K014211 | Oxyarm CO2 | Southmedic Inc. | CCK | Class II | |
| K013790 | Calcigen-S Bone Void Filer | Biomet Orthopedics, Inc. | MQV | Class II | |
| K013131 | Bioscrew Xtralok | Linvatec Corporation | HWC | Class II | |
| K013041 | Plexolong Sets | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | NCX | Class II | |
| K021850 | Synthes (USA) 1.3 Mm Craniofacial Screws | Synthes (USA) Products LLC | DZL | Class II | |
| K021833 | Modification to Blue Sky Dental Implant System | Blue Sky Bio, LLC | DZE | Class II | |
| K021743 | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: Yellow | Copioumed Intl., Inc. | LZA | Class I |