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 |
|---|---|---|---|---|---|
| K010966 | Medley Sp02 Module, Model 8220 | CareFusion 303, Inc | DQA | Class II | |
| K010887 | Insulin Pen Needle Adapter | Ohana Needle Co. | FMI | Class II | |
| K010802 | Cardiac View, Model 2001 | Magna-Lab, Inc. | MOS | Class II | |
| K010791 | Remote Presence and Care System (Rpcs 5000) | Adsis, Ltd. | DXH | Class II | |
| K010186 | Welch Allyn Impact Blood Pressure System | Welch Allyn Inc | DXN | Class II | |
| K003778 | Breast-Board (Multiple) | Arplay Medical S.A. | IYE | Class II | |
| K003560 | Mar Cor Services Bicarb System | Mar Cor Services, Inc. | FIN | Class II | |
| K003288 | Origen Dual Lumen Catheter | OriGen Biomedical, Inc. | DQO | Class II | |
| K002343 | Sigma Delta | Penlon, Ltd. | CAD | Class II | |
| K011377 | Non-Sterile Powder-Free Blue Latex Examination Gloves, with and without Bubblegum Scenting & a Protein Labeling Claim (5 | Sgmp Co., Ltd. | LYY | Class I | |
| K011371 | Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw | Sgmp Co., Ltd. | LYY | Class I | |
| K011370 | Non-Sterile Powder Free Purple Latex Examination Glove with and without Grape Scent and with Protein Labeling (50 Microg | Sgmp Co., Ltd. | LYY | Class I | |
| K011364 | Custom Tci (Tinnitus Control Instrument) | Siemens Hearing Instruments, Inc. | KLW | Class II | |
| K011071 | Paradigm Quick-Set Infusion Set | Maersk Medical A/S | FPA | Class II | |
| K011033 | Dimension Lithium (Li) Flex Reagent Cartridge, Model Df 132 | Siemens Healthcare Diagnostics Inc. | JIH | Class II | |
| K011001 | Team-Up Tm Dental Electronic Anesthesia System | Satelec | LWM | Unclassified | |
| K010885 | Uni-Laser 470 | MEDART ApS | GEX | Class II | |
| K010875 | Hycare Latex Examination Glove, Powdered | Hycare Intl. Co., Ltd. | LYY | Class I | |
| K010862 | Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling Claim, 50 per Gram or Less of Total Water | Medtronic, Inc. | KGO | Class I | |
| K010799 | Combosafe Surgical Gowns, Non-Sterile (75X Reusable) | Standard Textile Co., Inc. | FYA | Class II | |
| K010724 | Sola 700,Sola 500, Sola 300 | Drager Medizintechnik GmbH | FTD | Class II | |
| K010455 | Rotachrom Heparin and Sta -Rotachrom Heparin | Diagnostica Stago, Inc. | KFF | Class II | |
| K002911 | Xscan32 Teleradiology Software | Radiographic Digital Imaging, Inc. | LLZ | Class II | |
| K011528 | Emit 2000 Phenobarbital Assay, Model Osr4d229 | Syva Co. | DLZ | Class II | |
| K011485 | Pinnacle Magnetic Resonance Imaging Scanner | Fonar Corp. | LNH | Class II | |
| K011466 | Qed Diode Detectors, Models 1112-1116 | Sun Nuclear Corporation | LNH | Class II | |
| K011437 | Synergy 4.0 Mm, 4.5 Mm Vls Screws | Interpore Cross Intl. | MNI | Class II | |
| K011390 | Bonus-Orthopedic Bone Screw Fixation System | Disc-O-Tech Medical Technologies, Ltd. | MBI | Class II | |
| K011082 | Tpo Igg Antibody Eia Test | Scimedx Corp. | JZO | Class II | |
| K011057 | Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-Xxxx | OraSure Technologies, Inc. | PJD | Class II | |
| K011055 | The O'neil Sterile Field Urinary Catheter Kit with Prep Pads | Go Medical Industries Pty., Ltd. | FCM | Class II | |
| K010963 | Sta-Liatest Free Protein S Test Kit | Diagnostica Stago, Inc. | GGP | Class II | |
| K010953 | Cell-Dyn 4000 Immuno T-Cell (Cd3/4/8) Assay | Abbott Medical | GKZ | Class II | |
| K010922 | Tri-Fix Spinal Fixation System | Endius, Inc. | MNI | Class II | |
| K010903 | Tri-Fix Spinal Fixation System | Endius, Inc. | MNI | Class II | |
| K010866 | Temp-a-Sure | Homecare Technologies, Ltd. | FLL | Class II | |
| K010856 | Sterile Brightway Brand Power-Free, Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less) Tested | Brightway Holdings Sdn. Bhd. | LYY | Class I | |
| K010697 | Unique Ambulatory EEG | Axon Systems, Inc. | GWQ | Class II | |
| K010545 | Tbw | Tri-Med, Inc. | NDL | Class II | |
| K010473 | Sparrowhawk Disposable | Atc Technologies Inc. | DWZ | Class II | |
| K010471 | Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569 | Irvine Biomedical. Inc. | DRF | Class II | |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing Assays | Accriva Diagnostics, Inc. | KFF | Class II | |
| K010108 | Uss-Line Extension | Synthes GmbH | MNI | Class II | |
| K010083 | Trapease Permanent Vena Cava Filter and Introduction Kit, Model 466-P306a | Cordis US Corp. | DTK | Class II | |
| K003983 | Stimuplex Hns-11 | Stockert GmbH | BXN | Class II | |
| K003937 | CPR Ezy Mask and Pad | Medteq Innovations Pty, Ltd. | LIX | Class II | |
| K003596 | Smith & Nephew Restim | Smith & Nephew, Inc. | IPF | Class II | |
| K003570 | Bacchus Thrombectomy Catheter (Btc), Model Btc-0755 | Bacchus Vascular, Inc. | MCW | Class II | |
| K003517 | Otres Toothbrush Sanitizer Model Tb100w | Otres, LLC | MCF | Class I | |
| K003062 | Bactec Mgit 960 Sir Kits | BD Becton Dickinson Vacutainer Systems Preanalytic | MJA | Class II |