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 |
|---|---|---|---|---|---|
| K864203 | Nesbit Evans Nursing Home Bed | J. Nesbit Evans & Co. | FNJ | Class I | |
| K864137 | Lyphochek Immunoassay Serum Control Level I,ii,iii | Bio-Rad | KIJ | Class I | |
| K864115 | Tubegripper, Drainage Catheter & Accessory for Su | Cathaid, Inc. | KGZ | Class I | |
| K864105 | Lung Mechanics Software Program | Siemens Elema AB | CBK | Class II | |
| K864094 | Gambro Fluid Control Monitor Fcm 10-1 | Gambro, Inc. | FKP | Class II | |
| K864089 | Hitachi Electronic Thermometer Model Hk-10Ta | Hitachi Sales Corporation of America | FLL | Class II | |
| K864087 | Peds Pulmonary Evaluation & Diagnostic System | Medical Associated Services, Inc. | BTY | Class II | |
| K864072 | Adec 1005-C Chair | Cherne Industries, Inc. | LGX | Class I | |
| K864045 | Portable Oxygen Generator | Mountain Medical Equipment, Inc. | CAW | Class II | |
| K864023 | Eye Pad, Cotton, Gauze Covered | Fraass Survival Systems, Inc. | |||
| K863975 | Custom in-the-Ear | GN Danavox, Inc. | ESD | Class I | |
| K863955 | Colby Level Alarm | Respiratory Care, Inc. | BTT | Class II | |
| K863782 | Npg Nonprecious Crown and Bridge Alloy | Aalba Dent, Inc. | EJH | Class II | |
| K863755 | Vent-Plant Dental Implant, Osseolock and Robutment | Vent-Plant Corporation, Inc. | DZE | Class II | |
| K863186 | Biochem Co/ox 1000 | Biochem International, Inc. | DQA | Class II | |
| K863082 | Cook-Vpi Intermittent Catheter | Cook Incorporated | KOD | Class II | |
| K862919 | Transpirator(tm) Mt-1000 Personal Humidifier | Transpirator Technologics, Inc. | KFZ | Class I | |
| K862553 | ECG Module | Elscint, Inc. | DPS | Class II | |
| K862384 | Schein Ap-1 Air Polishing Unit | Henry Schein, Inc. | KOJ | Class II | |
| K861435 | Bunn Concentrator Model 2011 with Demand Valve | The John Bunn Co. | CAW | Class II | |
| K860994 | Decitel Ausculscope | Bloomfield Research and Development, Inc. | DQD | Class II | |
| K855177 | Norelco Electrnic Digital Blood Pressure Meter | Philips Park | DXN | Class II | |
| K864169 | Fresenius Hemoflow F50 & F70 | Seratronics, Inc. | KDI | Class II | |
| K864167 | Percluder(tm)-Dl Occluding Balloon(heparin Coated) | Datascope Corp. | |||
| K864083 | Gambro Bicarbonate Monitor Bcm 10-2 | Gambro, Inc. | FKP | Class II | |
| K863823 | Amicon Diafilter Hemofilter | Amicon, Inc. | KDI | Class II | |
| K863114 | Piastrinit | J. D. Assoc. | GGK | Class I | |
| K861731 | Natural Detector System | U.S. Health Resources Corp. | KHE | Class II | |
| K860734 | Series 7200 Transport/remote Acquisition Monitor | Marquette Electronics, Inc. | DPS | Class II | |
| K864180 | Integra, Custom in-the-Ear Hearing Aid | Bernafon LLC | ESD | Class I | |
| K864175 | Sponge, Surgical, Gauze, Compressed 2 by 2 Inches | Fraass Survival Systems, Inc. | EFQ | Unclassified | |
| K864146 | Deknatel Gwathmey Vascular Stapling Kit (Tenative) | Cardio Thoracic Systems | GDW | Class II | |
| K864139 | Ranfac Cut Biopsy Needle | Ranfac Corp. | GAA | Class I | |
| K864102 | Ligaclip 20/20* Multiple Clip Applier | Ethicon, Inc | FZP | Class II | |
| K864097 | Widex Hearing Aid Model Es2 | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K863888 | Du Pont Phenytoin Assay and Calibrator | E.I. Dupont de Nemours & Co., Inc. | DIR | Class II | |
| K863887 | Smi Multipettor(tm) | American Dade | JQW | Class I | |
| K863840 | Meth. & Cali. for the Dimension Clini/chem. System | E.I. Dupont de Nemours & Co., Inc. | JJE | Class I | |
| K863802 | Vmax Kinetic Microplate Reader | Molecular Devices Corp. | JJQ | Class I | |
| K863744 | Hcg Control Kit | Monoclonal Antibodies, Inc. | JJX | Class I | |
| K863738 | Emds(tm) Creatinine(crea) Testpacks, #67669/95 | Em Diagnostic Systems, Inc. | CGX | Class II | |
| K863521 | Lytening 2 | Amdev, Inc. | JGS | Class II | |
| K863490 | Ortho* Chlamydia Antigen Elisa Test & Transport | Ortho Diagnostic Systems, Inc. | LJC | Class I | |
| K863475 | Theofast(tm) Test Package | 3M Company | LER | Class II | |
| K862984 | Unidex Glucose Test Strip | Unidex, Inc. | CGA | Class II | |
| K862946 | Oxoid Signal Blood Culture System | Oxoid U.S.A., Inc. | JSG | Class I | |
| K862421 | Serum Clonazepam Toxicology Control | Utak Laboratories Inc | LAS | Class I | |
| K861425 | Sub-Vent (Tm) Implant/endosseous Blade Implant | Core-Vent Corp. | DZE | Class II | |
| K861211 | Mono Acu-Slide Test | Cal-Tech Diagnostics, Inc. | JHJ | Class II | |
| K864176 | Gentle Feel | Mali, Inc. | HFS | Class I |