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 |
|---|---|---|---|---|---|
| K012719 | Navigus II Mr | Image-Guided Neurologics, Inc. | HAW | Class II | |
| K012625 | Reprocessed Unipolar Laparoscopic/endoscopic Instruments | Alliance Medical Corp. | GEI | Class II | |
| K012529 | Rok | Southern Dental Industries, Inc. | EBF | Class II | |
| K012528 | Ice | Southern Dental Industries, Inc. | EBF | Class II | |
| K012503 | Metal Screw Anchor | Biomet Manufacturing Corp | MBI | Class II | |
| K012457 | Sodem High Speed System (Electric) (Neuro/spine Surgery) | Sodemsystems | HBC | Class II | |
| K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | HBC | Class II | |
| K011814 | Ameditech Immutest Drug Screen Coc | Ameditech, Inc. | DIO | Class II | |
| K011813 | Ameditech Immutest Drug Screen Thc | Ameditech, Inc. | LDJ | Class II | |
| K011502 | Crystal and Crystal-Care Implants System | Crystal-Seal Dental Implants | DZE | Class II | |
| K011392 | Micra Lens Injector, Micra Cartridge Lens, Micra Lens Loader | Micra Instruments | MSS | Class I | |
| K013356 | Wilson-Cook Ultrasound Biopsy Needle | Wilson-Cook Medical Inc. | FCG | Class II | |
| K013275 | Astralis 10, Models # 559588, 561859 | Ivoclar Vivadent, Inc. | EBZ | Class II | |
| K013162 | 14F X 24Cm Ash Split-Cath,14f X 28Cm Ash Split-Cath, 14F X 32Cm Ash Split-Cath, 14Fx36cm Ash Split-Cath, 14F X 40Cm Ash | Medcomp | KNT | Class II | |
| K013156 | Modification to Alarmview Wireless Data Network System | Data Critical Corp. | MSX | Class II | |
| K013154 | Mark Ii/mark III Manometric Perfusion Pump | Dentsleeve Pty., Ltd. | FFX | Class II | |
| K013153 | Autotome Rx Model # 4515, 4516 | Boston Scientific Corporation | KNS | Class II | |
| K013144 | Dual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard Feeding/decompression Tube, Model 00220W | C.R. Bard Inc | KNT | Class II | |
| K013135 | Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2kun6 (600 Tests) | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K013016 | True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove | Tillotson Healthcare Corp. | LZA | Class I | |
| K012510 | Modification to: Lifemate Hemofiltration System | NxStage Medical Inc | KDI | Class II | |
| K012364 | Aml Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K012320 | Powerpro Battery System | Linvatec Corporation | HAB | Class I | |
| K012309 | Riwo System Trays | Richard Wolf Medical Instruments Corp. | FEB | Class II | |
| K013279 | Mosfet Autosense, Model Tn-Rd-60 | Thomson & Nielsen Electronics, Ltd. | IYE | Class II | |
| K013150 | Mr-Guide 2000 | Ultraguide, Ltd. | LNH | Class II | |
| K013130 | N Lp(a) Control Sy | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K012961 | Sulzer Orthopedics Converge Acetabular System | Sulzer Orthopedics, Inc. | JDI | Class II | |
| K012726 | Prosafe Safety Syringe | Hou-Se Medical, Inc. | MEG | Class II | |
| K012522 | Wavelength Multi-Purpose Ultrasound Gel | National Therapy Products Inc. | ITX | Class II | |
| K012424 | Shimadzu Image Amplifier Model # Ia-16Lm | Shimadzu Corp. | JAA | Class II | |
| K012409 | Lorenz Lactosorb Laryngotracheal Reconstruction Implants | Biomet Microfixation | NHB | Class II | |
| K003857 | Sterilmed Intermittent Compression System, Garment Models 400 Series | Sterilmed Inc | JOW | Class II | |
| K002132 | Asha Treatment Planning System, Model Asha Tps | Intelligent Instruments Pvt., Ltd. | MUJ | Class II | |
| K013236 | Luxabite | Dmg USA, Inc. | ELW | Class II | |
| K013192 | Sonicator Plus 930, Model Me 930 | Mettler Electronics Corp | IMI | Class II | |
| K012403 | Vanguard Reprocessed Compression Garment | Stryker Sustainability Solutions | JOW | Class II | |
| K012333 | Flexi-Site Sp02 Ear Sensor | Epic Medical Equipment Services, Inc. | DPZ | Class II | |
| K012278 | Theken Small Cement Restrictor | Theken Surgical,Llc | JDK | Class II | |
| K012265 | Metal Halide Light Source, Models Mv-9088-T, Mv-9088 | Circon Video | FCW | Class II | |
| K011247 | Holy Dragon Sterile Acupuncture Needle for Single Use | Acusupply, Inc. | MQX | Class II | |
| K010032 | Seed Selectron Model V. 1.0 | Nucletron BV | JAQ | Class II | |
| K013322 | Hac-420 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K013235 | Modification to Synchron Control | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K013215 | Modified Ins-1 Intraoperative Nerve Surveillance System | NuVasive Inc | BXM | Class II | |
| K013176 | Modification to: Sens-a-Ray System with Proimage Software | Afp Imaging Corp. | EHD | Class II | |
| K013159 | Hrh-63-8 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K013137 | Algo 3 Newborn Hearing Screener | Bio-Logic Systems Corp. | GWJ | Class II | |
| K012900 | Access Unconjugated Estriol Calibrators | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K012878 | Thermo Trace Ammonia Standards Set, Models Tr-609 | Thermo Dma, Inc. | JIS | Class II |