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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K812934 | Monoject Prefilled Syringes | Sherwood Medical Co. | FMF | Class II | |
| K812933 | Lancer Specimen Container | Sherwood Medical Co. | FMH | Class I | |
| K812927 | Arteriogram Tray | American Pharmaseal Div. Ahsc | FMG | Class II | |
| K812926 | Alt-Quantichrom | Abbott Medical | CKA | Class I | |
| K812923 | S/p Sure-Cap N | American Dade | GIO | Class I | |
| K812922 | S/p Sure-Cap C | American Dade | GIO | Class I | |
| K812921 | S/p Sure-Cap | American Dade | GIO | Class I | |
| K812918 | Pilling K Knife | Narco Scientific | HNN | Class I | |
| K812917 | Portable Lidocaine Infusion Pump | Cardiac Pacemakers, Inc. | FRN | Class II | |
| K812916 | Mezlocillin 75Mcg Antimicrob. Suscept. D | General Diagnostics | JTN | Class II | |
| K812911 | Bcye Medium | Gibco Laboratories Life Technologies, Inc. | JSE | Class I | |
| K812910 | Medisystems Needles & Syringes | Medisystems Corp. | FMI | Class II | |
| K812899 | Med-Ex | Chattanooga Group, Inc. | LBB | Class II | |
| K812894 | Vdrl Carbon Antigen | Oxoid U.S.A., Inc. | GMQ | Class II | |
| K812863 | Fetasonde 5, #30, Central Nursing Stat | Kontron Instruments, Inc. | HGM | Class II | |
| K812856 | Chemical Indicators | Sterilization Technical Services, Inc. | JOJ | Class II | |
| K812855 | Ventronics #5595 Ecii Oxygen Analyzer | Ventronics, Div of Hudson Oxygen Therapy Sales Co. | CCL | Class II | |
| K812854 | Ventronics #5590 Ecii Oxygen Monitor | Ventronics, Div of Hudson Oxygen Therapy Sales Co. | CCL | Class II | |
| K812831 | Surgical Dressings | Foreign Trade Zone of Wisconsin | GDY | Class I | |
| K812814 | Zee Surgical Instruments | Zee Medical Products Co., Inc. | GDZ | Class I | |
| K812809 | Sterile Adherent Drapes | Abco Dealers, Inc. | KKX | Class II | |
| K812775 | Fluoricon L300 Image Intensifier | General Electric Co. | JAA | Class II | |
| K812769 | Trident #2001 | Trident Surgical Corp. | GEI | Class II | |
| K812736 | Softcare Barrier Wet Dressing | The Kendal Co. | EFQ | Unclassified | |
| K812735 | Cloth Surgical Gloves | Medical Synergy | KGO | Class I | |
| K812432 | Health-Up | Wfx Industries, Inc. | GZJ | Class II | |
| K812230 | Model Rs 8300 | Renal Systems, Inc. | LIF | Class II | |
| K812137 | B-D Heparinized Longdwel i.v. Catheter | BD Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | |
| K810850 | Personal Medication Infuser | Pacesetter Systems | FRN | Class II | |
| K812832 | Model 325C Unipolar Cardiac Pulse Gen. | Cook Pacemaker Corp. | DXY | Class III | |
| K812727 | Gastrin 1-17 by Radioimmunoassay Kit | Immuno Nuclear Corp. | CGC | Class I | |
| K812726 | Kermath Therapy Simulator | Kermath Mfg. Corp. | KPQ | Class II | |
| K812722 | Safe Guard | Concept, Inc. | GEI | Class II | |
| K812720 | Bodai Patient Communicator | Sontek Industries, Inc. | ILQ | Class II | |
| K812713 | Drawer Test | Medmetric Corp. | FTY | Class I | |
| K812702 | Technicator | Cameron-Miller, Inc. | GEI | Class II | |
| K812700 | Uricar | Hi Chem, Inc. | KNK | Class I | |
| K812642 | Engstrom Erica | Lkb Instruments, Inc. | CBK | Class II | |
| K812213 | Automated Electrocautery System | University of Washington | KNS | Class II | |
| K811021 | Herpes | Immuno-Diagnostic Products, Inc. | GQN | Class II | |
| K812721 | Digitron | Siemens Corp. | IZI | Class II | |
| K812965 | Model Sc-6, Flexible Siamoidoscope | American Optical Corp. | FAM | Class II | |
| K812924 | Answer (R) | Armkel, LLC | JHJ | Class II | |
| K812919 | Multi-Gram Developing Tank R-12 & R-3 | Marion Laboratories, Inc. | DKK | Class I | |
| K812912 | Gilchem Alp Reagent | Gilford Diagnostics | CJE | Class II | |
| K812907 | Femex | Promac | KNX | Class II | |
| K812895 | Yarmo Nasal Cartilage Softener | American V. Mueller | KAE | Class I | |
| K812884 | Narco Telecare Pressure Transducer Dome | Narco Scientific | DRS | Class II | |
| K812883 | Telecare Isotec Pressure Transducer Dome | Narco Scientific | DRS | Class II | |
| K812878 | The New 1600 Electrode | Andover Medical, Inc. | DRX | Class II |