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 |
|---|---|---|---|---|---|
| K060887 | Angiodynamic, Inc. Morpheus CT Picc and Procedure Kit | Boston Scientific Corporation | LJS | Class II | |
| K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs | Carmel Pharma AB. | LHI | Class II | |
| K060864 | Multidirectional Threaded Peg | Hand Innovations, Inc. | LXT | Class II | |
| K060778 | Synthetic Vinyl Patient Examination Glove-Powder Free | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K060761 | Breathscan, Breath and Breath Check Alcohol Detectors | Akers Biosciences, Inc. | DJZ | Class I | |
| K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series) | Safety Syringes, Inc. | MEG | Class II | |
| K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | JJX | Class I | |
| K060654 | Dsi Pins and Wires | Delta Surgical Instruments, Inc. | HTY | Class II | |
| K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | LPH | Class II | |
| K060577 | Ortho Development Ceramic Femoral Heads | Ortho Development Corp. | LZO | Class II | |
| K060567 | Spectragenics Ats-1 | Spectragenics, Inc. | GEX | Class II | |
| K060472 | Premise Flowable | Kerr Corporation | EBF | Class II | |
| K060461 | V-505 Infa Warmer | Atom Medical Corporation | FMT | Class II | |
| K060370 | Nexgen Knee Gender Solutions Female (Gsf) Femoral Components | Zimmer GmbH | JWH | Class II | |
| K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corporation | CGA | Class II | |
| K060339 | Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery | Tyco Healthcare/Kendall | NGT | Class II | |
| K060336 | Navitrack System-Os Knee Universal, Model Pro-05002 | Orthosoft, Inc. | HAW | Class II | |
| K060317 | Anthogyr Contra Angles and Handpieces | Est. Anthogyr | EGS | Class I | |
| K060222 | Low Back Pain Relief System /Models Gm310pp,gm320pp,gm321pp, and Gm330pp | Gemore Technology Co., Ltd. | NUH | Class II | |
| K060147 | Powder Free Nitrile Examination Gloves, Blue | Hongye Plastic Products Co., Ltd. | LZA | Class I | |
| K060139 | Crp-Advance Assay, Models 250-20, 250-25 | Sekisui Diagnostics P.E.I. Inc. | DCK | Class II | |
| K060093 | Presep Oligon Oximetry Catheters | Edwards Lifesciences LLC | DQE | Class II | |
| K053265 | Micrus Guide Wire, Watusi 0.014 | Micrus Endovascular Corporation | DQX | Class II | |
| K052996 | Porous Titanium Acetabular Shells | Biomet Manufacturing Corp | LPH | Class II | |
| K060920 | Velscope | Led Medical Diagnostics, Inc. | NXV | Class II | |
| K060877 | Palmaz Blue .014 Transhepatic Biliary Stent System-Model Pb1550,bas,bax,pb1560,bas,bax,pb1850,bas,baxpb1860bas,bax | Cordis US Corp. | FGE | Class II | |
| K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model Blue: All Sizes (Xs-Xl) | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K060441 | Vita Vm 7, Model Nx77 Xxxx, Nx78xxxx, Nx79 Xxxx; Vita Vm 8, Model Vx60 Xxxx, Vx61 Xxxx, Vx62 Xxxx; Vita Vm 9, Model Nx98 | Vident | EIH | Class II | |
| K060413 | Intact Breast Lesion Excision System and Advance | Intact Medical Corporation | KNW | Class II | |
| K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical Ltd. | GEH | Class II | |
| K060089 | Tulip Disposable Cannulas | Cell Bio-Systems, Inc. | QPB | Class II | |
| K060085 | Stryker Scope/instrument Holder | Stryker Corp. | GCJ | Class II | |
| K053535 | Vivawave Microwave Ablation System | Medtronic, Inc. | NEY | Class II | |
| K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra Inc. | DQY | Class II | |
| K053187 | Amplatzer Noodlewire Guidewire | Abbott Medical | DQX | Class II | |
| K053078 | Ergoselect 100 K/p, Ergoselect 200 K/p | Ergoline GmbH | ISD | Class II | |
| K052670 | Staxx Xd System | Spine Wave Inc | MQP | Class II | |
| K051419 | Inditherm Patient Warming System, Models Mecu1; Otm1; Otm2; Gtm1; Ptm1; Otb; Rb1 | Inditherm Medical | DWJ | Class II | |
| K060990 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | NKB | Class II | |
| K060710 | Universal Locking System, 3.5Mm Plates and Screws-4936 Plates,4835 Screws | Zimmer GmbH | HWC | Class II | |
| K060447 | Bd Phoenix Automated Microbiology System -Nitrofurantoin (Gn) 8-512 Ug/ml, Trimethoprim-Sulfamethoxazole (Gn) | Becton Dickinson & Co | LON | Class II | |
| K060392 | Asp Titanium | Sedatelec | MQX | Class II | |
| K060377 | Dr Disposable Prophy Angle Model H310 | Dental Resources | EGS | Class I | |
| K060308 | Coolgard 3000 | Alsius Corp. | NCX | Class II | |
| K053612 | Dri-Stat Acid Phosphatase Reagent | Siemens Healthcare Diagnostics Inc. | CKB | Class II | |
| K053572 | C. Diff Quik Chek | Techlab, Inc. | MCB | Class I | |
| K052929 | Preftest Professional Suite | Limestone Technologies, Inc. | LIL | Unclassified | |
| K052611 | Ecp Health System, Model 2005 | Ecp Health, Inc. | DRN | Class II | |
| DEN060001 | Phical Test | Genova Diagnostics | NXO | Class II | |
| K060845 | Monochrome Lcd Monitor, Radiforce Model Gs310 | Eizo Nanao Corporation | LLZ | Class II |