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 |
|---|---|---|---|---|---|
| K000304 | Hardydisk, Tetracycline 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000293 | Barco Mgd 221 2 Megapixel Diagnostic Display | Barco N.V. | LLZ | Class II | |
| K000292 | Barco Mwd 321 Plus Medical Workstation Display | Barco N.V. | LLZ | Class II | |
| K000154 | Eliachar Laryngeal Foam Stent, Model Ell-1 | E. Benson Hood Lab, Inc. | FWN | Class II | |
| K000019 | Single Size Tendon Spacer | Medist International | HXA | Class II | |
| K994430 | Impact.wf Mobile Waveform Receiving System | General Electric Medical Systems Information Techn | MSX | Class II | |
| K994423 | Automated Non-Invasive Blood Pressure Monitor, Model Bpm-100 | Vsm Medtech, Ltd. | DXN | Class II | |
| K994278 | Access Ostase Immunoenzymetric Assay | Siemens Healthcare Diagnostics Inc. | CIN | Class II | |
| K994194 | (Tas) Low Range Heparin Management Card Rapidpoint | Cardiovascular Diagnostics, Inc. | JBP | Class II | |
| K993199 | Pocket Chamber Valved Aerosol Holding Chamber | Ferraris Medical, Inc. | CAF | Class II | |
| K993129 | Ucla/universal Abutment | Diamodent | DZE | Class II | |
| K993060 | Gas Filter | Olson Medical Sales, Inc. | JOD | Class II | |
| K981093 | Wesco Blanket | Wesco, Inc. | DWJ | Class II | |
| K000660 | Escort II+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411, 20412, 20413 | Medical Data Electronics | DRO | Class II | |
| K000495 | Ballard Medical Products Epidural and Spinal Needles | Ballard Medical Products | BSP | Class II | |
| K000013 | Acist Angiographic Injection System, Model R-2000 | Acist Medical Systems, Inc. | DXT | Class II | |
| K994389 | Cobe Hvr 2200 Hardshell Venous Reservoir, Filtered | LivaNova USA, Inc. | DTN | Class II | |
| K993896 | Mca-601, C-Arm Mobile | Medison Radiology Systems, Inc. | JAA | Class II | |
| K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron BV | MUJ | Class II | |
| K991133 | Mlc Fit | Elekta Limited | IYE | Class II | |
| K983214 | Rita RF Generator and Accessories, Model 500 Series | Boston Scientific Corporation | GXD | Class II | |
| K000600 | Syva Emit 2000 Thyroxine Assay, Calibrators | Syva Co., Dade Behring, Inc. | KLI | Class II | |
| K000469 | Randox Complement C3 | Randox Laboratories, Limited | CZW | Class II | |
| K000468 | Randox Complement C4 | Randox Laboratories, Limited | DBI | Class II | |
| K000393 | Nova Cordless Curing Light | Nova/Da Vinci Systems, Inc. | EBZ | Class II | |
| K000315 | Ventricular Analysis Toolkit Option | GE Healthcare | LNH | Class II | |
| K000294 | Mfcd 120 | Barco N.V. | LLZ | Class II | |
| K000291 | Mfcd 118 | Barco N.V. | LLZ | Class II | |
| K000115 | Retic Chex Linearity | Streck Laboratories, Inc. | JPK | Class II | |
| K000060 | Gel Mark Biopsy Site Marker, Models Mkooo1, Mk0004, Mk0007 | Senorx, Inc. | GDW | Class II | |
| K994376 | Frialit-2 3.4Mm Steeped Cylinder Implant with Frios Tps Coating; Frialit-2 3.4Mm Steeped Cylinder Implant with Frios Ha | Friadent GmbH | DZE | Class II | |
| K994373 | Hdi 1500/Sa 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (Mtp7-4) | Atl Ultrasound, Inc. | ITX | Class II | |
| K994370 | Ortho Development Balanced Knee System | Ortho Development Corp. | JWH | Class II | |
| K994230 | Ulticare Disposable Syringe | Ultimed, Inc. | FMF | Class II | |
| K993194 | Rusch Manual Resuscitator Bag | Rusch, Inc. | BTM | Class II | |
| K993191 | Tfx Medical Introducer Assembly | Tfx Medical, Inc. | DYB | Class II | |
| K000821 | Abbott Gemstar i.v. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1 Therapy Configuration | Abbott Medical | FRN | Class II | |
| K000679 | Thrombostrate Control Plasmas | Pacific Hemostasis | GGN | Class II | |
| K000598 | 5F Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K000436 | Belleglass Hp Translucent Dentin | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K000302 | Hardy Disk, Penicillin, 10 Units | Hardy Diagnostics | JTN | Class II | |
| K000169 | Nupro Prophylaxis Paste with Fluoride and Triclosan | Dentsply Intl. | EJR | Class I | |
| K000021 | Aesculap Bone Wax | Aesculap Inc | MTJ | Unclassified | |
| K994431 | Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7800 Series | Shimadzu Medical Systems | JAK | Class II | |
| K994011 | Ep Medsystems, Ep-Workmate | Abbott Medical | DQK | Class II | |
| K993826 | Narkomed 6000 | Draeger, Inc. | MLC | Class II | |
| K993757 | Solar 7/8000 | General Electric Medical Systems Information Techn | DSI | Class II | |
| K993303 | Semi Compliant (Sc) 35 Balloon Dilatation Catheter | Boston Scientific Corporation | FGE | Class II | |
| K993292 | Boston Scientific/target Sentry Occlusion Balloon Catheter | Boston Scientific Corporation | MJN | Class II | |
| K992174 | Pilling Weck Surgical Aortic Spoon-Jaw Clamp | Pilling Weck Surgical | DXC | Class II |