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 |
|---|---|---|---|---|---|
| K915208 | Fsh Enzyme Immunassay Test Kit No:kif4057 | Medix Biotech, Inc. | CGJ | Class I | |
| K915191 | Rai-Trol Elevated Lipids Control | Reagents Applications, Inc. | JJY | Class I | |
| K915077 | Synchron Creatinine Triggered Test Cx4,5,7, | Beckman Instruments, Inc. | CGX | Class II | |
| K914894 | Virapure, Chlamypure and Mycopure | Microtest | JSM | Class I | |
| K914871 | Trans Elec Nerve Stim/muscle Stim Elec W/poly Gel | Labeltape Meditect, Inc. | GZJ | Class II | |
| K914863 | Cordis Cinch(r) Steerable Guidewire Ext W/slx Coat | Cordis US Corp. | DQX | Class II | |
| K914794 | Technicon Chem 1 Plasma Glucose | Kulzer GmbH | CFR | Class II | |
| K914567 | Cordis Bipal Biopsy Forceps | Cordis US Corp. | DWZ | Class II | |
| K914539 | Rich-Mar Ifv 1000 | Rich-Mar Corp. | IPF | Class II | |
| K914530 | Ican Gt Drainage Bag | Icn Pharmaceuticals, Inc. | FRQ | Class II | |
| K914507 | Double Antibody Cannabionoids/quail Deter in Urine | Siemens Healthcare Diagnostics Inc. | LAT | Class II | |
| K914502 | Bard Pca II Pump with Program Cartridges | C.R. Bard Inc | MEA | Class II | |
| K914487 | Ohio Care Plus Incubator | GE Healthcare | FMZ | Class II | |
| K914422 | Devices for Vascu Intervent Rotat Hemostat Valve | Devices for Vascular Intervention, Inc. | DQY | Class II | |
| K914405 | Reads(r) Iga Anti-Cardiolipin Test Kit | Reads Medical Products, Inc. | MID | Class II | |
| K914269 | Edwards Anato Hook/univ Rod/wash/sacr Screw/adj Co | Scientific Spinal, Ltd. | KWP | Class II | |
| K914247 | Aspirating Endo Ocular Probe | Surgical Technologies, Inc. | EQH | Class I | |
| K914208 | Merit Disposal Depot(tm) | Merit Medical Systems, Inc. | DQO | Class II | |
| K914199 | Angiographic Soft Tip Catheter | E-Z-EM, Inc | DQO | Class II | |
| K914198 | Power Floss and Brush Ew 129 & Ew 120 | Matsushita Electric Co. | JEQ | Class I | |
| K914171 | In Vitro Diagnostic Regeant Set,cholinesterase | Tech Intl. Co. | DIH | Class I | |
| K914099 | Gas Trak Connect Blood Gas Control | Biochemical Sciences, Inc. | JPK | Class II | |
| K913954 | Marlow/reddick Laparoscopic Needle Holders | Marlo Surgical Technology | GCJ | Class II | |
| K913787 | Toxoplasma Igm Elisa Test System | Zeus Scientific LLC | LGD | Class II | |
| K913691 | Cps-Plus Cardioplegia Systems, Cat# Cps-X Series | Gish Biomedical, Inc. | DTR | Class II | |
| K913661 | Modified Volumetric Infusion Pump | Mcgaw, Inc. | FRN | Class II | |
| K913626 | Softrans Injector | Staar Surgical AG | HQL | Class III | |
| K913565 | Abbott Quickstart Cholesterol Test | Em Diagnostic Systems, Inc. | CHH | Class I | |
| K913287 | H/a Partial - Regular & H/a Partial - Offset | River Medical, Inc. | ETB | Class II | |
| K913286 | H/a Total-Regular, H/a Total-Offset | River Medical, Inc. | ETA | Class II | |
| K913285 | PTFE Piston | River Medical, Inc. | ETB | Class II | |
| K912799 | Eagle System | Marquette Electronics, Inc. | LMC | Class II | |
| K912498 | The Karl Storz 26025Uc Hamou Elec Hysteroflator | Karl Storz Endoscopy-America, Inc. | HIG | Class II | |
| K912028 | Uric Acid (Uricase) Reagent, Universal | Enzyme Technology, Inc. | KNK | Class I | |
| K911320 | Extravascular Doppler (Evd) Ultra Blood Flow Probe | Applied Biometrics, Inc. | JOP | Class II | |
| K910771 | Digitrace(tm) Home Monit Comp/elb(tm) EEG Lunch Bx | New England Medical Instruments, Inc. | OMB | Class II | |
| K910470 | Condoms, Moods/share & Rakshak | Hindustan Latex, Ltd. | HIS | Class II | |
| K905488 | Doppler Upgrade for Ausonics Opus 1 Real Time Scan | Ausonics Pty, Ltd. | LMB | Class I | |
| K905026 | Dual Flex Non-Latex | Mmi, Inc. | FGD | Class II | |
| K904556 | Mansfield Cardiac Assist Model 940(Tm) Iab | Boston Scientific Corporation | IOL | Class I | |
| K891411 | Gianturco-Wallace Tracheobronchial Z Stent | Cook Inc. | JCT | Class II | |
| K915393 | Mdt/shampaine Model 4900E Surgical Table | Mdt Corp., Inc. | GDC | Class I | |
| K915352 | Laser Fiberoptic Delivery System | Sunrise Technologies, Inc. | GEX | Class II | |
| K915197 | Precise Tm Hcg | Becton Dickinson Advanced Diagnostics | JHI | Class II | |
| K914835 | Lumatag Free T4 Chemiluminescence Assay | London Diagnostics, Inc. | CEC | Class II | |
| K914738 | Asl Model 101 | Adaptive Switch Laboratories, Inc. | ITI | Class II | |
| K914726 | Ilt CO2 Surgical Laser for Oral Soft Tissue Proced | Ion Laser Technology | GEX | Class II | |
| K914441 | Mens 2000-D | Monad Corp. | GZJ | Class II | |
| K914175 | Microsurge Laser Fiber with Sma Connector | Microsurge, Inc. | GEX | Class II | |
| K913746 | Smartneedle(tm) Vascular Access System | Peripheral Systems Group | ITX | Class II |