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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K853016 | Stille Angular Rongeur, 8-3/4 Ss 410 | The Huxley Instrument Corp. | |||
| K853010 | Cobas Reagent for Lidocaine & Calibrators | Roche Diagnostic Systems, Inc. | KLR | Class II | |
| K852993 | Bone Rongeurs | The Huxley Instrument Corp. | |||
| K852948 | Amresco Subst Concen, Pro #2432,Buf,nad,2455,tri | Amresco, Inc. | CFJ | Class II | |
| K852380 | Sparrow Motorized Scooter | Venturego, Inc. | INI | Class II | |
| K852379 | Sunbird (Powered Wheelchair) | Venturego, Inc. | ITI | Class II | |
| K852353 | Dg 200/300 Digital Angiographic System | Thomson-Cgr Medical Corp. | IXI | Class II | |
| K852276 | Esteem Incontinent System | Bevan Medical, Inc. | EYQ | Class I | |
| K852200 | Simplastic Supra Pubic Catheter | Franklin Medical USA, Inc. | KOB | Class II | |
| K852085 | Kendall Curity Urinary Output Monitor Drainage Bag | The Kendal Co. | KNX | Class II | |
| K852014 | Effner Sims Rectal Speculum W/fiber Optic Illumina | Effner and Spreine Co. | KOA | Class I | |
| K851813 | Therpac-Radiation Therapy Treatment Planning Syste | Victoreen, Inc. | KPQ | Class II | |
| K851689 | Genesys Gamma Counter | Laboratory Technologies, Inc. | JJJ | Class I | |
| K851660 | Donway Lifting Frame | Australian Biomedical Corporation, Ltd. | FPP | Class I | |
| K851483 | Urobei Stress Incontinence Monitor | Browne Medical, Inc. | FAP | Class II | |
| K850633 | Sharplan Model 1060 co/2 Surgical Laser | Laser Industries, Ltd. | GEX | Class II | |
| K850628 | Sharplan 1040 co/2 Surgical Laser | Laser Industries, Ltd. | GEX | Class II | |
| K853162 | Sterile Nasopharyngeal Airway | Inmed Corp. | BTQ | Class I | |
| K853146 | Respir Ther Humid Contain Sterile Water for Usp | Automatic Liquid Packaging, Inc. | BTT | Class II | |
| K853129 | Beaver Multipurpose Sapphire Knife | Rudolph Beaver, Inc. | HNN | Class I | |
| K853114 | Rotalok Wrist Strap, Rotalok Skin Retractor | Australian Biomedical Corporation, Ltd. | GAD | Class I | |
| K853103 | Mcknife | Medical Dimensions | GDX | Class I | |
| K853037 | Dr. Hessel's Vacuum Extractor | Medic Group of Scandinavia, Inc. | |||
| K853003 | Hi Chem Diagnostics Cleaning Neutralizer Sol#88193 | Hi Chem, Inc. | JJE | Class I | |
| K852435 | Ccs Implantable Maestro Series 100 Cardiac Pacema | Cardiac Control Systems, Inc. | DXY | Class III | |
| K852356 | Medtronic Model 5561 | Medtronic, Inc. | DTD | Class II | |
| K852062 | Saracap Respiratory Monitor | Alleghany Intl. Medical Technology | CCK | Class II | |
| K851924 | Liteguard 9 | Temtech, Ltd. | LDD | Class II | |
| K851888 | Apm Dispos. Blood Pressure Transducer | Honeywell, Inc. | DRS | Class II | |
| K851666 | Medi-Comp Neonatal Oxygen Hood | Medicomp, Inc. | BYL | Class I | |
| K851618 | Diascan Blood Glucose Self-Monitor Test Strips | Home Diagnostics, Inc. | CGA | Class II | |
| K851334 | Airlife Electronic Incentive Spirometer | American Pharmaseal Div. Ahsc | BWF | Class II | |
| K852954 | B-D Digital Fever Thermometer | BD Becton Dickinson Vacutainer Systems Preanalytic | FLL | Class II | |
| K852927 | Tdx Cortisol | Abbott Medical | JFT | Class II | |
| K851931 | Defi 2 | S & W Medico Teknik | LDD | Class II | |
| K851854 | Advanced Cardiovascular Sys Low Profile Pta Balloo | Advanced Cardiovascular Systems, Inc. | LIT | Class II | |
| K851744 | Equitest | Neurocom International, Inc. | LXV | Unclassified | |
| K851674 | Phakosystems Model Ces 4100 | Phakosystems, Inc. | HQC | Class II | |
| K851465 | Silent Guard Cat. No. Sg-30 | American Omni Medical, Inc. | DTL | Class II | |
| K851406 | Ajdjustable Suction Control Valve | American Omni Medical, Inc. | DWD | Class II | |
| K850952 | Bard Critical Care Thermodilutin Catheter W/infusi | C.R. Bard Inc | DYG | Class II | |
| K844918 | Occlusion & Occlusion-Irrigation | Clincal Instruments Corp. | DQT | Class II | |
| K844649 | Electrically Heated Sterilizer Steam Sterilizer | Takizawa Medical Instruments Manufacturer | FLE | Class II | |
| K853102 | Urease & Glutamate Dehydrogenase, Urea Nitrogen | Diagnostic Chemicals, Ltd. (USA) | CDQ | Class II | |
| K853084 | Medicon Model 8200 Ams(apnea Monitor System) | Aequitron Medical, Inc. | BZQ | Class II | |
| K853050 | Calcium Reagent for Astra 8 Autom Stat/rout/analyz | Simmler Inc | CIC | Class II | |
| K853049 | Albumin Reagent for Astra 8 Auto Stat/rout Analyze | Simmler Inc | CIX | Class II | |
| K853026 | Biovation Max Data Management System | Biovation, Inc. | JQP | Class I | |
| K852939 | Cortisol System by Eia | American Bioclinical, Inc. | CGR | Class II | |
| K852847 | Sopheia Dhea-So4 Eia Kit | Siemens Healthcare Diagnostics Inc. | JKC | Class I |