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 |
|---|---|---|---|---|---|
| K852060 | Infusion Sets Models 9120,9121,9125, 9122 & 9123 | Cardiac Pacemakers, Inc. | FRN | Class II | |
| K851935 | Edwards Sacral Screw | Zimmer GmbH | KWP | Class II | |
| K851918 | Infant Phototherapy Mask | Alba Health Care | FOK | Class I | |
| K851449 | Ohmeda 5000 Infant Warmer System | GE Healthcare | FMT | Class II | |
| K851407 | Surgical Towels | Diack | JOJ | Class II | |
| K851258 | Weck Lx Tm Skin Stapler | Edward Weck, Inc. | GAG | Class II | |
| K851195 | Vascular Access Catheter | Sil-Med Corp. | LJS | Class II | |
| K851016 | Passy-Muir Trach Valve | Passy & Passy, Inc. | BTO | Class II | |
| K850753 | Natural Mother Breast Pump | Crystal Medical Products, Inc. | HGX | Class II | |
| K850035 | Empty Solution Transfer Container | The Healthcare Group Laboratories, Inc. | KPE | Class II | |
| K844992 | Bio-Logic Portable Evoked Response System | Bio-Logic Systems Corp. | GWF | Class II | |
| K844963 | Vitapep | Vitalograph, Inc. | BWF | Class II | |
| K852118 | Manifold Clamps | Omser Sv., Inc. | DTL | Class II | |
| K851741 | Acculevel Theophylline Test(modification) | Syva Co. | KLS | Class II | |
| K851617 | Today Personal Lubricant | Vli Corp. | KMJ | Class I | |
| K851540 | Estradiol Direct Ria Kit | Biotecx Laboratories, Inc. | CHP | Class I | |
| K851181 | Preci-Jet 50 | Ulster Scientific, Inc. | KZE | Class II | |
| K850892 | Somatomedin C by Radioimmunoassay | Immuno Nuclear Corp. | CFL | Class I | |
| K850885 | Starcam Data Acquisition & Processing Sys H3300c | General Electric Co. | JWM | Class II | |
| K850872 | Phyaction 300, 360, 370, 390 & 391 Elec-Muscle-Sti | Ketronic, Inc. | |||
| K850619 | Bedside Patient Monitor W/modules | Midwest Analog & Digital, Inc. | DRT | Class II | |
| K844874 | Pennine Link Yankauers | Pennine Medical, Ltd. | GEA | Class I | |
| K843324 | Sprague Rappaport/sh-6008 Dispos. Steth | Cher Mel Corp. | LDE | Class I | |
| K842817 | Model 78353B | Hewlett-Packard Co. | DRT | Class II | |
| K842203 | Littman Type Sh-6010, Nurse Type | Cher Mel Corp. | LDE | Class I | |
| K852126 | Atf 101 Trail Frame | Ascon Medical Instruments, Ltd. | HPA | Class I | |
| K852056 | Acc Cross Cylinders | Ascon Medical Instruments, Ltd. | HPC | Class I | |
| K852019 | Belmont Autopan-Pan Oramic, 098E Cephalometric-Rad | Belmont Equipment Corp. | EAP | Class II | |
| K851878 | A Company Brass Separating Rings | A Company, Inc. | DZC | Class I | |
| K851851 | Sterile Endotracheal Brushes | Biological & Environmental Control Laboratories | |||
| K851842 | Spq Test System for C-Reactive Protein | Atlantic Antibodies | DCK | Class II | |
| K851812 | Digital Subtraction Antiography Phantom 76-700/711 | Victoreen, Inc. | IXF | Class I | |
| K851695 | Ultra-Neb 100 Ultrasonic Nebulizer | The Devilbiss Co. | |||
| K851687 | Jumbo Digital Gammacamera Gca-90B | Toshiba Medical Systems | JWM | Class II | |
| K851686 | Digital Gamma Camera Gca 501S | Toshiba Medical Systems | JWM | Class II | |
| K851649 | Apo a-I Immunoassay Test Set for Apolipoprotein A1 | Photec Diagnostics, Inc. | DER | Class II | |
| K851611 | Impact Turbo Cath | ZOLL Medical Corporation | JOL | Class II | |
| K851537 | Laser RF Control Serum-Quality Control Serum | Behring Diagnostics, Inc. | DHR | Class II | |
| K851440 | Rdiographic Wall Holder or Film Receptor | Summit Industries, LLC | IXY | Class I | |
| K851286 | Radial Immunodiffusion Plates C3 & C4 | Cooper Biomedical, Inc. | CZW | Class II | |
| K851211 | Phaco Pak I | United Sonics, Inc. | HQC | Class II | |
| K851069 | Body Type Hearing Aid 107S | Danavox, Inc. | ESD | Class I | |
| K851048 | Chest Catheters/thoracic Catheters | Medovations, Inc. | GBS | Class I | |
| K850914 | Hearing Aid, Unitron Model Uc | Unitron Industries, Inc. | ESD | Class I | |
| K850871 | Tredband Type I, It, II & III - Treadmills | Ketronic, Inc. | BXB | Class I | |
| K850711 | Inhalation Therapy Nebulizer Device | Med USA | KFZ | Class I | |
| K850535 | Mitrathane Dressing | Mitral Medical, Ltd. | NAD | Class I | |
| K850451 | J & J Ulcer Dressing | Johnson & Johnson Professionals, Inc. | FRO | Unclassified | |
| K844876 | Pennine Nelaton Catheters Sizes 5,6,8,10,12,14,16, | Pennine Medical, Ltd. | GBX | Class I | |
| K844357 | System 920 Argon/dye Photocoagulator | Coherent Medical Group | HQF | Class II |