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 |
|---|---|---|---|---|---|
| K864071 | Faulkner Forceps | Staar Surgical AG | HNR | Class I | |
| K864069 | Precept (Tm) Ticarcillin/clavulanic Acid | Austin Biological Laboratories | JWY | Class II | |
| K864063 | Orion 3001, Laser Photocoagulator | G. Rodenstock Instrumente GmbH | HQF | Class II | |
| K864037 | Kerascan Model 2000 Keratographic Auto Analyzer | Kera Corp. | HJB | Class I | |
| K864033 | Rapid Acid Fast Stain | Sigma Diagnostics, Inc. | KJY | Class I | |
| K864031 | Model Ak 8184 Custom-Low-Profile Hearing Aid | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K864030 | Model Aj8183 Custom-in-the-Ear Hearing Aid | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K864029 | Ay8182 Custom-Semi Canal-in-the-Ear Hearing Aid | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K864028 | Model Aq8181 Custom-Canal-in-the Ear Hearing Aid | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K863995 | Keynote | Sensory Aids Corp. | ILQ | Class II | |
| K863956 | Maculoscope(tm) | Doran Instruments, Inc. | GWE | Class II | |
| K863948 | A-Gent(tm) Liquid Glucose Trinder | Abbott Medical | CGA | Class II | |
| K863929 | Terumo Sensibead(tm) Eia Hlh Kit | Terumo Medical Corp. | CEP | Class I | |
| K863926 | Glucose Oxidase | Tech-Co, Inc. | CGA | Class II | |
| K863874 | Lipase Hydrolysis/glycerol Kinase, Triglycerides | Electro-Nucleonics Laboratories, Inc. | CDT | Class I | |
| K863756 | Modified Criterion Ventilator Breathing Circuit | Nova-Ventrx | BZO | Class I | |
| K863741 | Immuno-Cept D (Beta-Monoclonal) | Immunostics, Inc. | JHJ | Class II | |
| K863719 | Amylase,calcium,chloride & Triglycerides on Chem 1 | Technicon Instruments Corp. | CIJ | Class II | |
| K863670 | Vision (Tm) Calcium | Abbott Medical | CIC | Class II | |
| K863401 | Recover | Scientific Pharmaceuticals, Inc. | EBF | Class II | |
| K863363 | Cytotech Toxoplasma Igg Enzyme Immunoassay | Cytotech, Inc. | LGD | Class II | |
| K863300 | Q101 Diagnostic Spirometer | Quinton, Inc. | BYT | Class II | |
| K863158 | Model T-1 Oxygen Analyzer | Chrysalis Systems, Inc. | CCL | Class II | |
| K862799 | Skin Pure | Nihon Kohden America Inc | GYB | Class II | |
| K862419 | Serum Vancomycin Toxicology Control | Utak Laboratories Inc | LAS | Class I | |
| K862418 | Benzodiazepines Toxicology Control | Utak Laboratories Inc | LAS | Class I | |
| K862412 | Intestoplant | Burron Medical Products, Inc. | LLD | Class II | |
| K853827 | Life-Port Implantable Vascular Access | Strato Medical Corp. | LJT | Class II | |
| K852767 | Erythocyte Creatine | Panmed, Inc. | JLA | Class I | |
| K864130 | Abbott B2-Microglobulin Ria | Abbott Medical | JZG | Class II | |
| K863899 | K-Stik Defibrillation Pads | Katecho LLC | LDD | Class II | |
| K862683 | Biosoics Sphincter Training System | Biosonics, Inc. | KPN | Class II | |
| K862309 | Pc-Display | Hi-Tech Medical Systems, Inc. | LLZ | Class II | |
| K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | CBF | Class II | |
| K862098 | Pristine/blooming/pristine Blooming Culture Cath | Hall/Mccollum Laboratories, Inc. | KOD | Class II | |
| K864161 | Toob-Cheq Carbon Dioxide Gas Analyzer | Toob-Cheq, Inc. | BTR | Class II | |
| K864046 | C-Ioo Mobile Cine CT Unit | Imatron, Inc. | JAK | Class II | |
| K863983 | Exeter Operating Loupe | Exeter Instruments, Inc. | HJH | Class I | |
| K863974 | Charter Laboratories Inc. Lens Lubricant | Paco Pharmaceutical Services, Inc. | HPX | Unclassified | |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay Kit | Windsor Laboratories, Inc. | LGQ | Class II | |
| K863509 | Optec 1000 Dmv | Stereo Optical Company LLC | HOX | Class I | |
| K863096 | 5.O Mhz Sector Probe, Model 8818106 Lh 307 | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K863043 | 3.5 Mhz Sector Probe, Model 8818080 Lh 305 | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K863041 | 3.5 Mhz Sector Probe, Model 8818098 Lh306 | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K862841 | High Velocity Cw Doppler System | Biosound, Inc. | DPW | Class II | |
| K862614 | Rapid Identi. Test for Mycobacterium Tb Complex | Hologic, Inc. | LQF | Class I | |
| K862613 | Rapid Ident. Test for Mycobacterium Avium Complex | Hologic, Inc. | LQF | Class I | |
| K860467 | Electroshock Unit Neurology Model B-25 | Medcraft Corp. | QGH | Class II | |
| K855138 | Bovie Ultrasonic Surgical System | Clinical Technology Inc. | LBK | Unclassified | |
| K852547 | Cortronic Apm 770 Noninvasive & Arterial Press Mon | Cortronic Corp. | DQO | Class II |