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 |
|---|---|---|---|---|---|
| K991156 | Great Smokies Intestinal Permability Test System | Great Smokies Diagnostic Laboratory | JOC | Class I | |
| K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle | Becton Dickinson Vacutainer Systems | JKA | Class II | |
| K990844 | Stardental Axcs Sterile Water System | Dentalez Group | EIA | Class I | |
| K990736 | Gc Reline Soft/extra Soft | GC America Inc. | EBI | Class II | |
| K990734 | Dpd-12Pcc | Scanditronix Medical AB | IYE | Class II | |
| K990488 | Sensiflex Powderfree Latex Examination Glove | Terang Nusa (Malaysia) Sdn. Bhd. | LYY | Class I | |
| K990247 | Mtm Bioscanner Hdl, Model # Bsa450, Bsa460, Bsa470 | Polymer Technology Systems | LBR | Class I | |
| K984141 | Gbact + Kit | Sienco, Inc. | JBP | Class II | |
| K974342 | Roche Cobas Amplicor Ct/ng Test for Neisseria Gonorrhoeae | Roche Molecular Systems Inc | LSL | Class II | |
| K991703 | Stryker Hermes-Ready Total Performance System | Stryker Corp. | GCJ | Class II | |
| K991635 | Modification to Hermes Operating Room Control Center | Computer Motion, Inc. | GCJ | Class II | |
| K991527 | Chromophare D500, D530, D650 | Berchtold Holding GmbH | FSY | Class II | |
| K990968 | E-Scan | Esaote North America, Inc | LNH | Class II | |
| K990908 | Millennium | Endo Technic Corp. | MXF | Class II | |
| K990902 | Modification of Mlt R694 Ruby Laser System | Medical Laser Technologies Ltd. | GEX | Class II | |
| K990891 | Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing | Dermaphylyx, Inc. | FRO | Unclassified | |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing | Dermaphylyx, Inc. | MGP | Unclassified | |
| K990753 | Grac High Dose Rate (Hdr) Remote Afterloading Catheter | Cook Inc. | JAQ | Class II | |
| K990721 | Isolock Spinal System | Scien'Tx USA, Inc. | MNH | Class II | |
| K990663 | Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model Fp880-150 | MedTech LLC | GCJ | Class II | |
| K990432 | Surgisorb | Sutures, Ltd. | GAM | Class II | |
| K990015 | Electrode Needles | Technomed Europe | IKT | Class II | |
| K984614 | Normal Saline Flush Syringe | Rocap Div. of Sabratek Corp. | FOZ | Class II | |
| K983604 | Intra-Uterine Transfer, Intra-Folopian Transfer | Washington Regulatory Services | MQF | Class II | |
| K983551 | Crit-Scan II Monitor | In-Line Diagnostics Corp. | GKF | Class II | |
| K991673 | Cordis Tempo Angiography Catheter | Cordis US Corp. | DQO | Class II | |
| K991493 | Blue Powder-Free Nitrile Examination Gloves | Masju Sdn. Bhd. | LZA | Class I | |
| K991431 | 14 Fr. Hemodialysis Two-Lumen Catheterization Kit | Arrow Intl., Inc. | MPB | Class II | |
| K991415 | Supergloves, Polymer Coated Powder Free Latex Examination Gloves | Supermax Sdn Bhd | LYY | Class I | |
| K990963 | Rs Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile) | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K990739 | Quantec-E Endo System | Sybron Dental Specialties, Inc. | EKX | Class I | |
| K984497 | Temp Teller-Infrared Tympanic Thermometer, Models Tt-200, Tt-201 | Oriental System Technology, Inc. | FLL | Class II | |
| K984169 | Digi-Snap | Snap Laboratories, LLC | MNR | Class II | |
| K984135 | The Aptus (Automated) Application of the Hsv-1 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for | Zeus Scientific LLC | GQL | Class II | |
| K984120 | The Aptus(automated) Application of the Hsv-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for Th | Zeus Scientific LLC | GQL | Class II | |
| K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) Fo | Zeus Scientific LLC | LFX | Class II | |
| K981246 | Beverly Referential Valve (Nl850-9710) with Integral Peritoneal Catheter (Nl850-9720) Valve Kit (Nl850-9730) | Integra Neurocare, LLC | JXG | Class II | |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation Predictor (Cassette) | Selfcare, Inc. | CEP | Class I | |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) | Selfcare, Inc. | CEP | Class I | |
| K991247 | Uric Acid, Model Ua112-01 | A.P. Total Care, Inc. | KNK | Class I | |
| K991244 | Total Iron, Models Fe 109-01, Fe 109-02 | A.P. Total Care, Inc. | JMO | Class I | |
| K991111 | Buffer Chromogen (R1), Product No. Ca110-01, Edta Reagen (R2), Product No. Ca110-02 | A.P. Total Care, Inc. | CIC | Class II | |
| K991109 | Creatinine Reagent, Product No Cr105-01, Creatinine Reagent, Product No Cr105-02 | A.P. Total Care, Inc. | CGX | Class II | |
| K991108 | Carbon Dioxide (CO2), Product No. Cc0107-01 | A.P. Total Care, Inc. | KHS | Class II | |
| K990981 | Glucose, Hexokinase (R1), Model Gl101-01, Glucose Hexokinase (R2), Model Gl101-02 | A.P. Total Care, Inc. | CFR | Class II | |
| K990980 | Bun, Model Bu 104-01 | A.P. Total Care, Inc. | CDQ | Class II | |
| K990978 | Albumin Bcg, Model Al 103-01 | A.P. Total Care, Inc. | CJW | Class II | |
| K990763 | Vitron M | Espe Dental AG | EBI | Class II | |
| K990239 | Cobe Vvr 4000 Filtered Hardshell Venous Reservoir | LivaNova USA, Inc. | DTN | Class II | |
| K991231 | Hitachi Versiflex | FUJIFILM Healthcare Americas Corporation | IZI | Class II |