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 |
|---|---|---|---|---|---|
| K962155 | Gill-Thomas-Cosman(gtc) Dental Tray | Radionics Software Applications, Inc. | IYE | Class II | |
| K962114 | Arthro-Surgimat | Novanta Medical GmbH | HRX | Class II | |
| K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | MNR | Class II | |
| K962036 | Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/atrial, Transvenous Lead | Medtronic, Inc. | DTB | Class III | |
| K962013 | Mentor H/s Silicone Gel Sheeting for Scar Management | Mentor | MDA | Class I | |
| K961861 | Various Dental Implants with Cover Screws | Implant Management of America | DZE | Class II | |
| K961843 | Genie | Burton Medical Products Corp. | FSY | Class II | |
| K961768 | Kodak Digital Science Film Digitizer L7501/l7506 (with Film Autofeeder) | Kodak Health Imaging Systems, Inc. | LMA | Class II | |
| K961692 | Sonoscan | Sonotech, Inc. | ITX | Class II | |
| K961122 | Stryker Knifelight | Stryker Corp. | FTD | Class II | |
| K960903 | Karl Storz Inst. for Endoscopic Selective Perf. Vein Discission & Paratibial Fasciotomy | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K951052 | Weeks Applicator | Duke University Medical Center | IWJ | Class I | |
| K962974 | Sharplan Lasers, Inc. Af Acuspot Micromanipulator (713) | Sharplan Lasers, Inc. | GEX | Class II | |
| K962750 | 3M Trimatic Modular Advanced Processing System and 3M Aps Automatic Film Processor | Imation Corp. | IXW | Class II | |
| K962294 | Immage Immunochemistry System | Beckman Instruments, Inc. | JQX | Class I | |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) | Intermedics, Inc. | DTB | Class III | |
| K962072 | Proneb Turbo Compressor Model 38V0200 | Pari Holding Co. | CAF | Class II | |
| K962012 | Ethical Hearing Instruments/wizard Hearing Profile Tester | Ethical Hearing Instruments | EWO | Class II | |
| K961849 | The Roboguide | Shai Syg Motion and Innovations, Ltd. | IZH | Class II | |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/immunoassay Controls | Biocircuits Corp. | DHA | Class II | |
| K961416 | Dialysis Mixing & Holding Tank | Dial Medical Supply | FIN | Class II | |
| K960636 | Lasersonics Nd:yag Cylindrically Diffusing Sterile Disposable Fiber | Heraeus Surgical, Inc. | GEX | Class II | |
| K960321 | Cardiocath Catheterization Lab System | Prucka Engineering, Inc. | DPS | Class II | |
| K954932 | Bbl Mgit Products | Becton Dickinson Diagnostic Instrument Systems | MDB | Class I | |
| K954920 | Murex Rub-Ex | Murex Diagnostics, Inc. | LQN | Class II | |
| K963116 | Unsaturated Iron Binding Capacity (Uibc) Assay | Sekisui Diagnostics P.E.I. Inc. | JMO | Class I | |
| K963085 | Liquid Immunology Control Level I, II, III | International Enzymes, Inc. | JJX | Class I | |
| K962901 | Olympus B5-2C/b7-2C Balloon Catheter | OLYMPUS Corporation of the Americas | EOQ | Class II | |
| K962838 | Permaridge Syringe | Ceramed Corp. | LYC | Class II | |
| K962485 | Olympus Fg Series of Rat Tooth Grasping Forceps (ENT) | OLYMPUS Corporation of the Americas | EOQ | Class II | |
| K962386 | Sensor Sheath Ts1 | Radiotherapeutics Corp. | FLL | Class II | |
| K962369 | Talking Digital Thermometer | Ultmost Industrial Corp. | FLL | Class II | |
| K961207 | Ep-X Biplane | Fischer Imaging Corp. | JAA | Class II | |
| K954690 | Stryker Oral Max System | Stryker Corp. | DZI | Class II | |
| K953958 | Powderfree Blue Latex Exam Gloves with Protein Content Labeling Claim | Codan Medlon, Inc. | LYY | Class I | |
| K953956 | Blue Latex Exam Gloves with Protein Content Labeling Claim | Codan Medlon, Inc. | LYY | Class I | |
| K953955 | Powderfree Latex Exam Gloves with Protein Content Labeling Claim | Codan Medlon, Inc. | LYY | Class I | |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (Thc) | Tcpi, Inc. | LDJ | Class II | |
| K962808 | Ilizarov External Fixation System | Smith & Nephew Richards, Inc. | KTT | Class II | |
| K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | LMD | Class I | |
| K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | HXJ | Class I | |
| K962353 | Accusign Doa 5 (Thc/opi/coc/met or Amp/pcp) | Princeton BioMeditech Corp. | DIO | Class II | |
| K962261 | Implantech Wm Nasal-Labial Implant | Implantech Associates Inc | LZK | Class II | |
| K962227 | Pro-Fect Sterile Gauze Sponges | Network Trading Corp. dba Grand Intl. | EFQ | Unclassified | |
| K962186 | N-Geneous Hdl Cholesterol Kit/cholesterol Calibrator | Genzyme Corporation | LBR | Class I | |
| K962101 | Zweymueller Sl Femoral Hip Stem | Intermedics Orthopedics | LZO | Class II | |
| K962069 | Medline Pre-Powdered Non-Sterile/sterile Vinyl Examination Gloves | MEDLINE INDUSTRIES, LP - Northfield | LYZ | Class I | |
| K961829 | Qualitrol Crp Control Set | Consolidated Technologies, Inc. | DCK | Class II | |
| K961765 | Mpo Elisa Test System | Immunoprobe, Inc. | MOB | Class II | |
| K961764 | Pr-3 Elisa Test System | Immunoprobe, Inc. | MOB | Class II |