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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K896156 | Compass(tm) Stereotactic Retractor System | Stereotactic Medical Systems, Inc. | GZT | Class II | |
| K896093 | A-Port Implant. Vascular Access System - A2port | Therex Corp. | LJT | Class II | |
| K894778 | Codman RF-12 Disposable Scalp Clip Applier | Cerenovus, Inc. | HBO | Class II | |
| K893646 | Volumetric Pump Solution Set W/integral Airway | Baxter Healthcare Corporation | FPA | Class II | |
| K891237 | Model 600 Syringe Pump | 3M Company | FRN | Class II | |
| K896347 | Immunodot Autoimmune Screening Panel 1 | General Biometrics, Inc. | LJM | Class II | |
| K896220 | Non-Sterile Latex Examination Gloves | Allstar Sdn. Bhd. | LYY | Class I | |
| K895850 | Synchron Cx Systems (Lap) Reagent Kit | Beckman Instruments, Inc. | JGG | Class I | |
| K895821 | Uric Acid for Manual/automated Applications | Catachem, Inc. | KNK | Class I | |
| K895785 | Audiometer Model Md-4, Md-4P | Singer Medical Products, Inc. | EWO | Class II | |
| K895784 | Impedance Analyzer/audiometer Model Md-3 | Singer Medical Products, Inc. | EWO | Class II | |
| K895783 | Impedance Analyzer Models Md-2, Md-P | Singer Medical Products, Inc. | ETY | Class II | |
| K895642 | Latex Patient Examination Gloves | Siam Sempermed Corp., Ltd. | OPE | ||
| K895322 | Latex Examination Gloves | Advantage Resources | LYY | Class I | |
| K894748 | Impedance Anal/screening Audiometer Md-1 & Md-1P | Singer Medical Products, Inc. | EWO | Class II | |
| K894308 | Patient Examination Gloves | Xing Huao Co., Ltd. | LYY | Class I | |
| K893660 | ECG Simulator Model Ecgplus | Bio-Tek Instruments, Inc. | DPS | Class II | |
| K893357 | Latex Examination Gloves | M.M. Rubber Co., Ltd. | LYY | Class I | |
| K892926 | Dual Lumen Catheter for Chronic Vascular Access | Vas-Cath, Inc. | LJS | Class II | |
| K892328 | Featherweight Vinyl, Non-Sterile Exam Gloves | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K892327 | Tru-Touch Vinyl, Sterile | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K892073 | Tagum Latex Examination Gloves | Tagum Rubber Industries, Ltd. | LYY | Class I | |
| K891719 | Tru-Touch Vinyl, Non-Sterile | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K891121 | Medi-Tech Amplatz Introducer Shealth System | Boston Scientific Corporation | DYB | Class II | |
| K896592 | Ciba Corning Magic Lite Sq Specific Ige Assay | Ciba Corning Diagnostics Corp. | DHB | Class II | |
| K896585 | Modified Ferritin Enzyme Immunoassay Test Kit | Medix Biotech, Inc. | DBF | Class II | |
| K896367 | Sterile Surgical Drapes and Sheets | Clinitech, Inc. | KKX | Class II | |
| K896131 | Gnathomat Articulator | Ivoclar North America, Inc. | EJP | Class I | |
| K895958 | Brevet Floss Pick (Autoclave Sterilizer) | Brevet Inc. | EKJ | Class I | |
| K895663 | Site 810E Photocoagulator and Accessories | Site Microsurgical Systems, Inc. | GEX | Class II | |
| K895434 | Alcon Folding Forceps | Alcon Laboratories | HNR | Class I | |
| K895401 | Northernlights Orthodontic Bonding System | Rocky Mountain Orthodontics, Inc. | EBF | Class II | |
| K895393 | Sarns Ingant Membrane Oxygenator | 3M Company | DTZ | Class II | |
| K895104 | Aquatrex Underwater Treadmill System | Edmonds Medical Systems | IOL | Class I | |
| K892453 | Kulzer Glas-Ionomer Cement | Kulzer GmbH | EMA | Class II | |
| K892412 | Polyether-Retarder | Espe GmbH (US) | ELW | Class II | |
| K896545 | Activated Partial Thromboplastin Time (Aptt) | Sigma Chemical Co. | GFO | Class II | |
| K896483 | Qm300 Alpha2 Macroglobulin Antibody Pack | Kallestad Diag, A Div. of Erbamont, Inc. | DEB | Class II | |
| K896291 | Injection Port II --- for Intermittent Injection | The Medi-Dose Group | FPA | Class II | |
| K896207 | Osbon Personal Lubricant | Osbon Medical Systems, Ltd. | KMJ | Class I | |
| K896196 | Arthroscopy Disp. & Reusable Shaver Blades, Rechar | Orthoconcept, Inc. | HRX | Class II | |
| K896163 | Schneider Stent Wallstent Endoscopic Biliary Endo. | Schneider Stent | FGE | Class II | |
| K896135 | Strawberry Scented Latex Examination Gloves | Arista Latindo Industrial, Ltd. P.T. | LYY | Class I | |
| K895912 | Immunocard Hcg II-S Test Kit | Disease Detection International, Inc. | JHI | Class II | |
| K895886 | Biopro Hemi-Endo Modular Head for Psl System | Biopro, Inc. | KWL | Class II | |
| K895870 | Isoscreen-Ck Confirmatory Kit | Roche Diagnostic Systems, Inc. | JHY | Class II | |
| K895831 | Needlepoint Guard | Needlepoint Guard, Inc. | FMF | Class II | |
| K895809 | Milenia(tm) Hcg (Mkcg1,5) | Siemens Healthcare Diagnostics Inc. | JHI | Class II | |
| K895488 | Latex Patient Examination Gloves | Zhong YI Latex Products Factory | LYY | Class I | |
| K895480 | Blunt Needle Port/i.v. Port | Applied Medical Technologies | FPA | Class II |