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 |
|---|---|---|---|---|---|
| K944062 | Laprascopic Grasper | Instrument Makar, Inc. | GCS | Class II | |
| K943546 | Fukuda Sangyo Model Spiroanalyzer St-180 | Spirosoft Northamerica, Inc. | BZG | Class II | |
| K943194 | Immulite(r) Allergy Food Panel Fp5e | Siemens Healthcare Diagnostics Inc. | DGO | Class II | |
| K943193 | Coat-a-Count(r) Estradiol-6 | Siemens Healthcare Diagnostics Inc. | CHP | Class I | |
| K942828 | Makar Full and Half Face Shield | Instrument Makar, Inc. | LYU | Class I | |
| K941487 | Instent Esophacoil Esophageal Prosthesis | Instent, Inc. | ESW | Class II | |
| K940264 | Vasogenics Eecp-Mc2 | Vasogenics, Inc. | DRN | Class II | |
| K921695 | Ultra Cover Ultrasound Transducer Probe Covers | Parker Laboratories, Inc. | ITX | Class II | |
| K950399 | RNA Medical's Equil Plus with Glucose Control | Bionostics, Inc. | JJY | Class I | |
| K950228 | Dsl Active Igfbp-3 Irma (Dsl 6600) | Diagnostic Systems Laboratories, Inc. | CFL | Class I | |
| K950166 | Olympus Kd-6G1-9Q Wire Guided Papillotomu Knife | OLYMPUS Corporation of the Americas | KNS | Class II | |
| K950139 | Drugs of Abuse Calibrator | E.I. Dupont de Nemours & Co., Inc. | DKB | Class II | |
| K950138 | Drugs of Abuse Controls | E.I. Dupont de Nemours & Co., Inc. | DIF | Class I | |
| K946381 | Sunglasses | Ialin Optical Mfg., (H.K.) Co. Ltd. | HQY | Class I | |
| K946183 | Clinitek Atlas Automated Urine Chemistry Analyzer | Kulzer GmbH | KQO | Class I | |
| K946163 | Radias Total T4 Enzyme Immunoassay | Bio-Rad | KLI | Class II | |
| K946153 | Digoxin Flex(tm) Reagent Cartridge | E.I. Dupont de Nemours & Co., Inc. | KXT | Class II | |
| K946124 | Hemagen Ena Jo-1 Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K946123 | Hemagen Ena Sm Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K946122 | Hemagen Ena Scl-70 Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K946121 | Hemagen Ena Ss-a Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K946120 | Hemagen Ena Ss-B Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K946067 | Total Cholesterol, Hdl Cholesterol, Triglycerides and Glucose Panel | Cholestech Corp. | CHH | Class I | |
| K946066 | Total Cholesterol, Hdl Cholesterol and Glucose Panel | Cholestech Corp. | CHH | Class I | |
| K946065 | Total Cholesterolm Hdl Cholesterol and Triglycerides Panel | Cholestech Corp. | CHH | Class I | |
| K946064 | Total Cholesterol Cassette | Cholestech Corp. | CHH | Class I | |
| K946063 | Total Cholesterol and Hdl Cholesterol Panel | Cholestech Corp. | CHH | Class I | |
| K945993 | Vapofil | Southmedic Inc. | CAD | Class II | |
| K945609 | Abusign(tm) Coc, Doa-Coc, Accusign(tm) Coc, Doa-Coc, Diosign(tm) Coc, Doa-Coc | Princeton BioMeditech Corp. | DIO | Class II | |
| K945550 | Abusign(tm) Thc, Doa-Thc, Accusign(tm) Thc, Doa-Thc, Diosign(tm) Thc, Doa-Thc | Princeton BioMeditech Corp. | LDJ | Class II | |
| K945408 | 340-Chloride for Discrete Random Access Analyzer | Catachem, Inc. | CHJ | Class II | |
| K944851 | Micro Mini Primo Agc, Micro-Mini Primo S-Agc | Rexton, Inc. | ESD | Class I | |
| K944697 | Aura Flex Ft4 200 Test Pack, Ft4 Calibrator Pack | bioMerieux, Inc. | CEC | Class II | |
| K944541 | Handypack 911Sc | Pace Tech, Inc. | CCK | Class II | |
| K944325 | Lifesign, Care Point, Vitalsign, Accusign | Princeton BioMeditech Corp. | JHW | Class II | |
| K943736 | Cvpro Cardiovascular Patch | W. L. Gore & Associates, Inc. | DXZ | Class II | |
| K943439 | Abusign Doa4 | Princeton BioMeditech Corp. | DKZ | Class II | |
| K942145 | Non-Uniform Attenuation Correction System | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K941762 | Intergrated Monitoring Archiving and Communications Systems (Imacs) | Hogan & Hartson | DQK | Class II | |
| K940548 | Mic Percutaneous Endoscopic Jejunal Feeding Tube | Medical Innovations, Inc. | KNT | Class II | |
| K940158 | Emit Iic Cannabinoid Assay | Syva Co. | LDJ | Class II | |
| K935352 | Emit(r) Iic Amphetamine Assay | Syva Co. | DKZ | Class II | |
| K935323 | Emit Iic Cocaine Metabolite Assay | Syva Co. | DIO | Class II | |
| K935191 | Emit Iic Phencyclidine Assay | Syva Co. | LCM | Unclassified | |
| K935116 | Emit Iic Barbiturate Assay | Syva Co. | DIS | Class II | |
| K950447 | Filter/hch Product Number 5710Hepa, 5710Filt | Vital Signs, Inc. | BYD | Class I | |
| K950403 | Surgical Saw Blades | Transidyne General Corp. | GFA | Class I | |
| K950392 | 4-O2 Plus (CPR) Mouth Barrier, Catalog No. 08050 | Cal West Trading Co. | CBP | Class II | |
| K950055 | A4722 Olympus Optical Obturator | OLYMPUS Corporation of the Americas | HIH | Class II | |
| K945667 | Micos Micropulse(tm) Alternating Pressure Wheelchair Cushion | Micos Medical Systems | KIC | Class I |