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 |
|---|---|---|---|---|---|
| K081401 | Mayfield Mr/x-Ray Skull Clamp | Integra LifeSciences Corporation | HBL | Class II | |
| K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001 | Boston Scientific Corporation | DQX | Class II | |
| K082784 | Jumao Manual Wheelchair | Danyang Jumao Healthcare Equipment Co., Ltd. | IOR | Class I | |
| K082618 | Ultra Trak Pro Blood Glucose Monitoring System, Model Td-455 | Taidoc Technology Corporation | NBW | Class II | |
| K082608 | Radius Spinal System, Vitallium Rod #486613601 | Howmedica Osteonics Corp | NKB | Class II | |
| K082442 | Modification to Microfuse Bone Void Filler | Globus Medical, Inc. | MQV | Class II | |
| K081952 | Synergy Spinal System (6.35 Polaris) | Highridge Medical, LLC | NKB | Class II | |
| K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | IYE | Class II | |
| K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants | Astra Tech, Inc. | NHA | Class II | |
| K081010 | Bard 3Dmax Mesh | Davol Inc., Sub. C.R. Bard, Inc. | FTL | Class II | |
| DEN070003 | Neurostar Tms System | Neuronetics Inc. | OBP | Class II | |
| K082664 | Jetstream Pathway Pv Atherectomy System, Model Pv10300, Pvcn100 | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K082663 | Color Lcd Monitor | Eizo Nanao Corporation | LLZ | Class II | |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep a | Princeton BioMeditech Corp. | GTY | Class I | |
| K082301 | Grind No More | Placontrol, Inc. | OBR | Unclassified | |
| K082271 | Fluconazole 25Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K082217 | Ranger Rapid Flow Blood/fluid Warming System | Arizant Healthcare, Inc. | LGZ | Class II | |
| K082149 | Lympha Press Optimal, Model# 1201Ap | MEGO AFEK AC Ltd. | JOW | Class II | |
| K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310) | Spinal Concepts, Inc. | NKB | Class II | |
| K081820 | Avalon Elite Bi-Caval Dual Lumen Catheter, 13Fr, 16Fr, 19Fr, 20Fr, 23Fr, 27Fr, 31Fr | Avalon Laboratories, LLC | DWF | Class II | |
| K081478 | RNA Medical Glucose and B-Ketone Calibration Verification Controls | Bionostics, Inc. | JJX | Class I | |
| K071969 | Sen-4100 Electric Stimulator | Nihon Kohden America Inc | GWF | Class II | |
| K082633 | Intellivue Patient Monitor, Intellivue Xds, Models Mp2, Mp5, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | DSI | Class II | |
| K082577 | Pass Lp Spinal System | Medicrea Technologies | MNH | Class II | |
| K082567 | Stryker Compartmental Knee System Line Extension | Howmedica Osteonics Corp | HRY | Class II | |
| K082544 | Quart Arterial Filter with Bioline Coating | MAQUET CARDIOPULMONARY GmbH | DTM | Class II | |
| K082515 | Asahi Rexeed-Sx/lx Dialyzers, Models: 13Sx, 15Sx, 18Sx, 21Sx, 25Sx, 13Lx, 15Lx, 18Lx, 21Lx | Asahi Kasei Medical Co., Ltd. | KDI | Class II | |
| K082069 | Pass 2 Spinal System | Medicrea Technologies | MNI | Class II | |
| K081933 | Avalon Elite Multi-Port Venous Femoral Catheter, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr | Avalon Laboratories, LLC | DWF | Class II | |
| K081842 | Engstrom Carestation, Engstrom Pro | GE Healthcare | CBK | Class II | |
| K081799 | Gore Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | DQY | Class II | |
| K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed, Inc. | OBH | Class II | |
| K080786 | Ml830tp | Microlight Corporation of America | ILY | Class II | |
| K082587 | Auto-Safety Injector-2 (Asi-2) | Medical House Products Limited | KZH | Class II | |
| K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | Mallinckrodt Medical | BTR | Class II | |
| K082461 | Bare Platinum Framing Coil, Model(s) 100408Bpfc-V,100412bpfc-V,100515bpfc-V100518bpfc-V,100522bpfc-V,100618bpfc-V100622b | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K082272 | Voriconazole 1Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K082109 | Bovie Icon General Purpose RF Generator | Apyx Medical Corporation | GEI | Class II | |
| K082106 | Elcam Antimicrobial Closed Stopcocks (Dss and Tss) | Elcam Medical A.C.A.L. | FMG | Class II | |
| K082071 | Adpharma Occlude and Occlude F Dentin Tubule Agent | Adpharma, Inc. | LBH | Class II | |
| K082058 | Dynamatrix | Cook Biotech, Inc. | NPL | Class II | |
| K081995 | Stryker Vision Elect Whdtv (Stryker Ve Whdtv) | Stryker Corp. | GCJ | Class II | |
| K081880 | Atlas Spine Spacer | Atlas Spine, Inc. | ODP | Class II | |
| K081611 | Nuvasive Coroent System | NuVasive Inc | ODP | Class II | |
| K081545 | One Series Ultra Cartridge, Model 1Vipr30 | Advanced Medical Optics, Inc. | MSS | Class I | |
| K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | QEW | Class II | |
| K080052 | Stryker Essx with Navigation Mount | Stryker Corp. | ERL | Class II | |
| K073700 | 6F Proxis System | Abbott Medical | DQY | Class II | |
| K082764 | Straumann Wn Cares Titanium Abutment | Straumann USA, LLC | NHA | Class II | |
| K082757 | Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation System | Bioplate Inc | JEY | Class II |