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 |
|---|---|---|---|---|---|
| K840352 | Cin-Shear | Roland J. Zwick, Inc. | HFB | Class I | |
| K840329 | Ristocetin Cofactor Assay | Helena Laboratories, Corp. | GGP | Class II | |
| K840312 | Cat. 8 Dental Devices | Imm Enterprises, Ltd. | EMG | Class I | |
| K840268 | Irrigation System | MEDLINE INDUSTRIES, LP - Northfield | EXD | Class II | |
| K840260 | Periograf Durapatite 40-60 Mesh | Sterling Drug, Inc. | LYC | Class II | |
| K840253 | One-Way Air Valve | Delta Medical Industries | BYZ | Class II | |
| K840237 | Max-I-Probe Periodontal Endodontic Prob | Smith & Nephew, Mpl Division | EIC | Class I | |
| K840186 | Smi Digitron | Scientific Manufacturing Industries | JRC | Class I | |
| K840093 | Dental Flossing Instrument | Leverette Corp. | JES | Class I | |
| K840033 | Hypodermic Needles & Stylets | Microvasive | FMI | Class II | |
| K834610 | Laser Lens-Various Models | Meditec of America | HQF | Class II | |
| K834574 | Usci Endoprosthesis | C.R. Bard Inc | FGE | Class II | |
| K834446 | Alexotek Lingual Tubes | Alexotek Co. | DZD | Class I | |
| K834340 | Iocare Irrigation & Aspiration Pack | Chiron Vision Corp. | HQC | Class II | |
| K833802 | Infant Warmer | KCI USA, Inc. | FMT | Class II | |
| K833706 | Click-Count U100 Insulin Syringe | Orange Medical Instruments, Inc. | FMF | Class II | |
| K832977 | Flow-Pac Cpk Reagent Set | American Research Products Co. | JHY | Class II | |
| K841405 | Injection Cap or Adaptor | Medcare Disp Products, Inc. | |||
| K841222 | Bacteroides Bile Esculin Gar | Anaerobe Systems | JSI | Class I | |
| K841221 | Brain Heart Infusion Broth | Anaerobe Systems | JSC | Class I | |
| K841220 | Anaerobic Transport Medium | Anaerobe Systems | JSL | Class I | |
| K841219 | Shopped Meat Carbohydrate | Anaerobe Systems | JSC | Class I | |
| K841213 | Antimicrobial Suscept-Culture Media | Smith River Biologicals | JTZ | Class II | |
| K841212 | Single Biochemical Test | Smith River Biologicals | JSF | Class I | |
| K841210 | Selective & Non-Differential | Smith River Biologicals | JSJ | Class I | |
| K841205 | Non Propagating Transport | Smith River Biologicals | JSM | Class I | |
| K841203 | General Nutrient Broth | Smith River Biologicals | JSG | Class I | |
| K841170 | Sickle Hb Assay | Isolab, Inc. | GHM | Class II | |
| K841138 | Mueller Hinton Agar W/blood & Cofactor | Anaerobe Systems | JTZ | Class II | |
| K841117 | Gaspak Plus Dispos. Hydrogen & | BD Becton Dickinson Vacutainer Systems Preanalytic | KZJ | Class I | |
| K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | IPF | Class II | |
| K841029 | Bangort Lifestyle Colostomy Pouches | Howmedica Corp. | EXB | Class I | |
| K841026 | Manual Blood Cell Counting Device | Instrumentation Laboratory Co. | GKM | Class I | |
| K840999 | Philly Infant Bolt | Philadelphia Medical Specialties | GWM | Class II | |
| K840916 | Dieto Container for Enternal Nutrit | Gil-Med Industries C/O Kegan & Kegan, Ltd. | KNT | Class II | |
| K840863 | Seratest RF Latex Determination | Seragen Diagnostics, Inc. | DHR | Class II | |
| K840847 | Immpulse Tobramycin Assay Reagents | Paragon Diagnostics, Inc. | LCR | Class II | |
| K840831 | Endotome Pneumatic Orthopaedic Cut | Cabot Medical Corp. | HSZ | Class I | |
| K840810 | Swabzyme-Oxidase | E-Y Laboratories, Inc. | JTO | Class I | |
| K840794 | S-Cal Hematology Calibrator | Coulter Electronics, Inc. | KRY | Class II | |
| K840783 | Creatine Kinase Mb Reagent | American Dade | CGS | Class II | |
| K840776 | Paramax Cholesterol Reagent | American Dade | CHH | Class I | |
| K840775 | Carbon Dioxide Calibrator II | American Dade | JIT | Class II | |
| K840774 | Carbon Dioxide Calibrator I | American Dade | JIT | Class II | |
| K840773 | Carbon Dioxide Reagent | American Dade | KHS | Class II | |
| K840770 | Paramax Ammonia Reagentt | American Dade | JIF | Class I | |
| K840758 | Immpulse Theophylline Assay Reagents | Paragon Diagnostics, Inc. | LER | Class II | |
| K840719 | Bakteriette-VI-Pak | Great Lakes Intl. | JTW | Class I | |
| K840706 | Aspartate Aminotransferase Reagent | American Dade | CIT | Class II | |
| K840676 | Pdc Hdl Ez-Sep Cholesterol Reagent | Preventive Diagnostics Corp. | LBS | Class I |