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 |
|---|---|---|---|---|---|
| K010284 | Lyra G Series Surgical Laser System (Sl Series Q-Switched Nd:yag Configuration) | Laserscope | GEX | Class II | |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation | Welcon, Inc. | JOL | Class II | |
| K003064 | Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323 | Roche Diagnostics GmbH | DDG | Class II | |
| K002742 | Sphygmocor Mx Model Scor-Mx | Pwv Medical Pty, Lt. | DSK | Class II | |
| K002718 | Ultra Care 2 Latex Examination Gloves Made from Allotex (Enzyme Treated) Natural Rubber Latex with a Protein Content Lab | Tillotson Healthcare Corp. | LYY | Class I | |
| K010993 | Alien Rx Micro Cannula, Model 4530 | Boston Scientific Corporation | ODD | Class II | |
| K010886 | Simplicity Wing Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K010835 | Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp, Non-Sterile, Model 385 | Busse Hospital Disposables | HFW | Class II | |
| K010708 | Applicator Tip/dual Sprayer Kit | Interpore Cross Intl. | FMF | Class II | |
| K010365 | Ortho Control Female Urinary Control Device | Personal Products Co. | MNG | Class I | |
| K004038 | Total Pth Immunoradiometric Assay(irma) Diagnostic Kit, Model 3Kg600 | Scantibodies Laboratory Inc. | CEW | Class II | |
| K003812 | Vacuette Speedy Quick-Release Holder | Greiner Bio-One North America, Inc. | FMI | Class II | |
| K003023 | Cobe Hc 700 Midi Hemoconcentrator | Hospal Industrie | KDI | Class II | |
| K992607 | Sonicaid System 8002 | Oxford Instruments Medical Systems | HGM | Class II | |
| K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | Lsi Solutions Inc. | GCJ | Class II | |
| K010823 | Spazz | Colours 'N Motion | IOR | Class I | |
| K010789 | Cannula, Surgical General & Plastic Surgery, Modelr65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 | A & A Medical, Inc. | GCJ | Class II | |
| K010782 | Transamerican TENS | Transamerica Medical Systems | GZJ | Class II | |
| K010722 | Prolene (Polypropylene) 3D Patch, Nonabsorbable Synthetic Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K010665 | Transamerica Digital Ems | Transamerica Medical Systems | IPF | Class II | |
| K010662 | Modification to Tissuelink Monopolar Floating Ball | Medtronic Navigation, Inc | GEI | Class II | |
| K010529 | Titanium Cement Restrictor Material Pldla | Medtronic Sofamor Danek USA Inc | JDI | Class II | |
| K010509 | Cedars-Sinai Bpgs and Moco | Smv America | KPS | Class II | |
| K010371 | Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant | Suretex, Ltd. | HIS | Class II | |
| K010353 | Med-Logics Disposable Alk Tubing | Med-logics Inc | KYG | Class I | |
| K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | LMC | Class II | |
| K010268 | Fresenius Priming Set with Needles Access Port, Model 04-9002-9 | Fresenius Medical Care Renal Therapies Group, LLC | KOC | Class II | |
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set | Nipro Medical Corporation | FIB | Class II | |
| K010260 | Hansatome Microkeratome | Bausch & Lomb Incorporated | HNO | Class I | |
| K010178 | Spermicidal Lubricated Male Latex Condom | Innolatex Sdn. Bhd | LTZ | Class II | |
| K003740 | Miaspas Minitta Anterior Micro Surgical Transthoracic Approach Instrumentation | Aesculap Inc | HRX | Class II | |
| K003325 | Ksi's New Camera Architecture (Nca) Video Imaging System | Karl Storz Imaging, Inc. | FET | Class II | |
| K001915 | Graft Marker Ring | T. Korossurgical Instruments Corp. | MAB | Class II | |
| K000889 | Senoj Implant System | Senoj Biocare, Inc. | DZE | Class II | |
| K011086 | Hardydisk Bacitracin, 10Mcg, Model Z927 | Hardy Diagnostics | JTN | Class II | |
| K010962 | Emit II Plus Methadone Assay, Model Osre229 | Syva Co., Dade Behring, Inc. | DJR | Class II | |
| K010960 | Emit II Plus Ethyl Alcohol Assay, Model Osr9k229 | Syva Co., Dade Behring, Inc. | DIC | Class II | |
| K010955 | Bmt Anscore Health Management System | Boston Medical Technologies, Inc. | DPS | Class II | |
| K010726 | Modification to Mirage | Segami Corporation | LLZ | Class II | |
| K010670 | Piccolo Chloride Test System | Abaxis Inc | CHJ | Class II | |
| K010441 | Freelite Kappa Free Kit | The Binding Site | DEH | Class II | |
| K010440 | Freelite Lambda Free Kit | The Binding Site | DEH | Class II | |
| K010417 | Cal/rad Mark IV-Dose Calibrator 34-162 Veenstra Model # Vdc-304 | Nuclear Assoc., Div. Inovision LP | KPT | Class II | |
| K010283 | Theraseed(r) Palladium-103 Implant; Model 200 | Theragenics Corp. | KXK | Class II | |
| K010259 | Mediface Pacs | Mediface Co., Ltd. | LLZ | Class II | |
| K010252 | Magnum | Magnum Equipment LLC | JFB | Class II | |
| K004046 | Cobe Vvr 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir | LivaNova USA, Inc. | DTP | Class II | |
| K004010 | Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact Compact Controls | Roche Diagnostics GmbH | LFR | Class II | |
| K003987 | Urs-1K (Ketone Tesst) | Teco Diagnostics | JIN | Class I | |
| K003559 | Tci (Tinnitus Control Instrument) | Siemens Hearing Instruments, Inc. | KLW | Class II |