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 |
|---|---|---|---|---|---|
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification) | Cardio Metrics, Inc. | DQX | Class II | |
| K954085 | Models 5866-45 and 5866-46 Sizing Sleeve | Medtronic, Inc. | DTB | Class III | |
| K953779 | Saddle with Anchor, Stainless Steel Varifix System | Advanced Spine Fixation Systems, Inc. | MNH | Class II | |
| K953760 | Cordis Wizdom Steerable Guidewire | Cordis US Corp. | DQX | Class II | |
| K952773 | Mikro-Tip Angiographic Catheter | Millar LLC. | DQO | Class II | |
| K951369 | Edm | Deltex Medical Limited | DPW | Class II | |
| K950275 | Resorbable Soft Tissue Attachment Device | Zimmer GmbH | MAI | Class II | |
| K941144 | Excel EMG | Excel Tech., Ltd. | IKN | Class II | |
| K954796 | Micro-Ingressor Handipiece | Trebay Medical Corp. | ERL | Class II | |
| K954116 | Silicone Malecot Catheter with Pezzer/mushroom Tip | Technical Products, Inc. | FEW | Class II | |
| K954058 | Barraquer-Krumeich Refractive Set | Eyetech M.V.A. | HNO | Class I | |
| K954052 | Arthroscopic Grasper, Cup Forceps and Curettes | T. Korossurgical Instruments Corp. | HRX | Class II | |
| K954014 | Percutaneous Discectomy Cannula System | T. Korossurgical Instruments Corp. | HRX | Class II | |
| K953914 | Kentex | Kentron Health Care, Inc. | EFQ | Unclassified | |
| K953864 | Silclear Tubing (Modification) | Degania Silicone, Inc. | FPK | Class II | |
| K953809 | Karl Storz Take-Apart Biopolar Forceps | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K953792 | Consensus Zirconia Head Size -3.5, 0, +5 | U.S. Medical Products, Inc. | LZO | Class II | |
| K953778 | Saddle with Anchor, Titanium Varifix System | Advanced Spine Fixation Systems, Inc. | MNH | Class II | |
| K953719 | Human Tubal Fluid | Life Technologies Corporation | MFD | Class II | |
| K953709 | Derrick Safetouch | M.P.S. Pharm'L Int'L | LYY | Class I | |
| K953653 | Lubinus Sp II Hip System | Turnkey Intergration USA, Inc. | JDG | Class II | |
| K953438 | Surgical Integrated Camera System | Envision Medical Corp. | GCJ | Class II | |
| K952623 | Cryo Check Lupus Plasma | Precision Biologicals, Inc. | GGC | Class II | |
| K951485 | Avoximeter 4000 | A-Vox Systems, Inc. | JKS | Class I | |
| K950480 | Disposable ECG Monitoring Electrode #4539 28X45mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950478 | Disposable ECG Monitoring Electrode #4570 38X60mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950477 | Disposable ECG Monitoring Electrode #4560 38X60mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950474 | Disposable ECG Monitoring Electrode #4533 32X45mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950471 | Disposable ECG Monitoring Electrode #4580 32X45mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950470 | Disposable ECG Monitoring Electrode #4535 32X45mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950011 | Cohort(tm) Anterior Plate System (Aps) | Cohort Medical Products Group, Inc. | KWQ | Class II | |
| K943225 | Coamatic Factor VIII | Pharmacia Hepar, Inc. | GGP | Class II | |
| K940424 | Ventana Blue Detection Kit | Ventana Medical Systems Inc | DEH | Class II | |
| K954910 | Karl Storz Optical Mediastinoscope | Karl Storz Endoscopy-America, Inc. | EWY | Class II | |
| K954571 | Abusign Doa 3, Doa, Coc/thc/opi, Accusign Doa 3, Biosign Doa 3, Coc/thc/oopi | Princeton BioMeditech Corp. | DIO | Class II | |
| K954418 | Intact Parathyroid Hormone (Pth) Immunoassay (Modification) | Nichols Institute Diagnostics | CEW | Class II | |
| K954262 | Nexus II Femoral Component | Wrightmedicaltechnologyinc | JDI | Class II | |
| K954218 | Sterile Feeding Tube | Baxter Healthcare Corporation | FPD | Class II | |
| K954188 | Opticlone Igg1 Fitc/igg2a Pe Isotypic Control | IMMUNOTECH s.r.o. | GKZ | Class II | |
| K953650 | Depuy Stainless Steel Set Screw | Depuy, Inc. | HWC | Class II | |
| K953519 | Microspin 24 | Vulcon Technologies | GKF | Class II | |
| K953513 | Xenon Circuit | King Systems Corporation. | IYT | Class II | |
| K953286 | Fcp-9P, Fiber Choledochoscope | Pentax Precision Instrument Corp. | FBN | Class II | |
| K952893 | The Swirler Aerosol System | Amici, Inc. | CAF | Class II | |
| K952506 | Pyrilinks Assay Kit | Metra Biosystems, Inc. | JMM | Class I | |
| K952026 | Pyrilinks Polyclonal Assay Kit | Metra Biosystems, Inc. | JMM | Class I | |
| K951891 | Acl Futura Coagulation System | Instrumentation Laboratory Co. | JPA | Class II | |
| K950508 | Sysmex Sf-3000 | Sysmex Corporation | FPK | Class II | |
| K946170 | Comfort-Q Subcutaneous Injection Sets | B. Braun of America, Inc. | FOZ | Class II | |
| K945519 | Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System | Pharmaquest Corp. | MPG | Class I |