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 |
|---|---|---|---|---|---|
| K811925 | Uroflowmeter | C.R. Bard Inc | FFG | Class II | |
| K811893 | Novametrix Physiological Monitor #910 | Novametrix Medical Systems, Inc. | DRT | Class II | |
| K811848 | Model Six Beam System | Braintech, Inc. | GWF | Class II | |
| K811839 | Medisystem Negative Pressure | Medisystems Corp. | FJK | Class II | |
| K811838 | Medisystems Fistula Needle | Medisystems Corp. | FIE | Class II | |
| K811831 | Multi-Purpose Dental Syringe | Centrix, Inc. | EJI | Class II | |
| K811629 | Dyna- Mo | Philips North America LLC | IYX | Class I | |
| K811270 | Scope Master | Synemed, Inc. | HIH | Class II | |
| K812357 | Ventrex Data Reduction & Qual. Contr. Sy | Ventrex Laboratories, Inc. | JPK | Class II | |
| K812341 | Urea Nitrogen (Bun) | Horiba Instruments Incorporated | CDQ | Class II | |
| K812334 | B-Neocept | Organon LLC | JHJ | Class II | |
| K812329 | Zeta-Sera D | Amf Biological and Diagnostics Co. | KIS | Class I | |
| K812327 | Kappa & Lambda Bence Jones Controls | Kallestad Laboratories, Inc. | CZQ | Class II | |
| K812318 | Lipo-Sep Cholesterol Audit System | Isolab, Inc. | |||
| K812314 | Crithidna Anti-DNA Test Kit | Antibodies, Inc. | DHN | Class II | |
| K812313 | Sandare Uric Acid Procedure | Sandare Chemical Co., Inc. | LFQ | Class I | |
| K812303 | Glucose-Hk System Pack Test | Boehringer Mannheim Corp. | CFR | Class II | |
| K812289 | Celestin Dilator | Inmed Corp. | KNQ | Class II | |
| K812274 | Auramine O Mycrobacterial Stain Set | Carr-Scarborough Microbiologicals, Inc. | KJK | Class I | |
| K812253 | Gelman Ig-Fix Kit | Gelman Sciences, Inc. | CZP | Class II | |
| K812226 | Helena Hbf Quiplate Control | Helena Laboratories, Corp. | KQI | Class II | |
| K812215 | Antithrombin III Screen Kit | Pacific Hemostasis | JBQ | Class II | |
| K812212 | Acridine Orange Stain | Carr-Scarborough Microbiologicals, Inc. | IDC | Class I | |
| K812085 | Herpes Virus Hominis Antibody Test Sys. | Zeus Scientific LLC | GQL | Class II | |
| K811959 | Tandem Pap Kit - (Parts I & II) | Hybritech, Inc. | JFH | Class II | |
| K811342 | Reagent Strips for Urinalysis | Miles Laboratories, Inc. | JRE | Class I | |
| K812336 | Cobe Ppd 1.9 | Cobe Laboratories, Inc. | FJG | Class II | |
| K812319 | Therapy Bench | Kaye Products, Inc. | IOD | Class I | |
| K812308 | Lancer Bun Rate Reagent Kit | Sherwood Medical Co. | CDS | Class II | |
| K812296 | Gamma Glutamy Transpeptidase | Horiba Instruments Incorporated | JQB | Class I | |
| K812294 | Conveen Urisheath & Conveen Uriliner | Telcam Medical Devices, Inc. | KNX | Class II | |
| K812293 | Centrichem Cholesterol Reagent & Calibra | Baker Diagnostics | CHH | Class I | |
| K812290 | Fun-UV System Pack Test | Boehringer Mannheim Corp. | CDQ | Class II | |
| K812288 | Human C-Peptide Reagents | Immunex Radiochemical Diagnostics | JKD | Class I | |
| K812285 | Monoject Sterile Corvac Blood Tube | Sherwood Medical Co. | JKA | Class II | |
| K812271 | Central Station Monitor | Datascope Corp. | DRT | Class II | |
| K812261 | Accurate I | Organon LLC | JHJ | Class II | |
| K812258 | Acr Enzymatic Glucose Oxidase | Harleco | CGA | Class II | |
| K812254 | Dacron Pledget Suture Buttress | Ethicon, Inc | DXZ | Class II | |
| K812194 | Immunodiffusion Band Intensifying Fluid | American Scientific Products | JZS | Class I | |
| K812193 | Koh Mounting Fluid | American Scientific Products | LEB | Class I | |
| K812192 | Lacto-Phenol Aniline Blue Mounting Fluid | American Scientific Products | LED | Class I | |
| K812191 | Vaspar Sealent | American Scientific Products | KEO | Class I | |
| K812190 | Coccidioides Immunodiffusion System | American Scientific Products | GMI | Class II | |
| K812188 | Cryptococcal Antigen Latex Aggluti | American Scientific Products | GMD | Class II | |
| K812187 | Smith's Systemic Fungal Medium | American Scientific Products | JSI | Class I | |
| K812172 | Contact Lens Cleaner | Alcon Laboratories | HPX | Unclassified | |
| K812168 | Cordis Ducor Percut. Trans. Angio. Cath. | Cordis US Corp. | LIT | Class II | |
| K812167 | Model 78850 Oxygen Monitor | Hewlett-Packard Co. | KLK | Class II | |
| K812160 | Microsurgical Blade | Vxtra Corp. | GES | Class I |