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 |
|---|---|---|---|---|---|
| K051796 | Clearfil Tri-S Bond Single Dose | Kuraray Medical Kurashiki Plant | KLE | Class II | |
| K051754 | Orthoscan, Orthoscan Hd | Orthoscan, Inc. | OXO | Class II | |
| K051732 | Endoscopic Applicator | Ethicon, Inc | GCJ | Class II | |
| K051434 | Cooltouch Nd:yag Laser Systems, Models Ct3s and Ctev | New Star Lasers, Inc. | GEX | Class II | |
| K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | GEX | Class II | |
| K051368 | Br 102 Plus Blood Pressure Holter System | Schiller, AG | DXN | Class II | |
| K051014 | Silent Partner Series Osa Appliances | Dreamwrx Dental Laboratory | LRK | Class II | |
| K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL | Class II | |
| K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | GEX | Class II | |
| K050182 | Q.steps Biometer G/c Dual Monitoring System | Biomedix Wai | CGA | Class II | |
| K043224 | Gen-Probe Aptima Combo 2 Assay | Hologic, Inc. | LSL | Class II | |
| K040428 | Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural Foam | R & K International Cosmetics | NUC | Class II | |
| K051936 | Clever Check Td-3215/Dr. T Td-3216 Blood Glucose and Blood Pressure Measurement Systems | Taidoc Technology Corporation | NBW | Class II | |
| K051917 | Diver C.e. Catheter | Invatec Innovative Technologies, S.r.l. | QEZ | Class II | |
| K051808 | Estelite Flow Quick | Tokuyama Dental Corporation | EBF | Class II | |
| K051409 | Slivasure | Scandinavian Formulas, Inc. | LED | Class I | |
| K051200 | Hemoglobin A1c Reagent Set | Teco Diagnostics | LCP | Class II | |
| K051199 | Ipf (Immature Platelet Fraction) Parameter on the Sysmex Model Xe-2100 Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K051193 | Vascular Solutions Pronto Short Extraction Catheter | Vascular Solutions LLC | QEZ | Class II | |
| K051121 | Direct Ldl Cholesterol, Model L530-60H | Teco Diagnostics | MRR | Class I | |
| K050836 | Crp Diagnostic Assay | Sentinel CH SpA | DCK | Class II | |
| K050657 | Mondeal Contour Ho System | Kapp Surgical GmbH | HRS | Class II | |
| K050655 | Mondeal Radius Ho System, Model Ks-Mr-2005 | Kapp Surgical GmbH | HRS | Class II | |
| K052090 | Splash! Impression Material Device | Discus Dental LLC | ELW | Class II | |
| K052051 | Omni Sphincterotome | Wilson-Cook Medical Inc. | KNS | Class II | |
| K052037 | Modification to Hoffmann II Micro External Fixation System | Howmedica Osteonics Corp | KTT | Class II | |
| K051989 | Gii Quickanchor Plus with Orthocord Suture | DePuy Mitek, Inc. | JDR | Class II | |
| K051983 | Model 3000 Axyaloop Bio-Absorbable Bone Anchor | TORNIER Inc. | MAI | Class II | |
| K051949 | 4.5 Mm Ls Facet Compression Device with Polymer Washer, Model Lspw-45-3040 | Triage Medical, Inc. | MRW | Unclassified | |
| K051916 | Polar Cath Peripheral Dilatation System | Cryo Vascular Systems, Inc. | LIT | Class II | |
| K051884 | Charlotte Small Mtp Fusion Plate | Wrightmedicaltechnologyinc | HRS | Class II | |
| K051883 | Datex-Ohmeda S/5 EEG Module, E-EEG and Datex-Ohmeda S/5 EEG Headbox, N-EEG and Accessories. | GE Healthcare | OLT | Class II | |
| K051854 | Clever Chek Td-4225, Model Td-4225 | Taidoc Technology Corporation | NBW | Class II | |
| K051846 | 7F Sherpa Nx Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K051689 | Bd Phoenix Automated Microbiology System - Daptomycin 0.125 - 32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051570 | Avl Hinge Knee System | Zimmer GmbH | KRO | Class II | |
| K051539 | Tricot Blood Pressure Cuff | Ya Horng Electronic Co., Ltd. | DXQ | Class II | |
| K051503 | Ugytex Sual Knit Mesh | Sofradim Production | OTP | Class III | |
| K051385 | Explor Modular Radial Head Replacement Device | Zimmer GmbH | KWI | Class II | |
| K051322 | Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus | Abbott Medical | BTL | Class II | |
| K051231 | Verifynow-P2y12 Assay | Accumetrics, Inc. | JOZ | Class II | |
| K051042 | Metricath Gemini-P Balloon Catheter, Models Rx2515s-P, Rx3015s-P, Rx3515s-P, Rx4015s-P, Metricath Console, Model 1000 | Angiometrx, Inc. | LIT | Class II | |
| K043547 | Compress Segmental Femoral Replacement System | Zimmer GmbH | KWA | Class III | |
| K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | FTM | Class II | |
| K040627 | Depuy Asr Modular Acetabular Cup System | Depuy Orthopaedics Inc. | KWA | Class III | |
| K051971 | Optima Spinal System | CG MedTech Co., Ltd. | KWQ | Class II | |
| K051890 | Roche Diagnostics Cobas Elecsys Anti-Tpo | Roche Diagnostics GmbH | JZO | Class II | |
| K051814 | Jms Sysloc Mini A.v. Fistula Needle Set and Apheresis Needle Set | JMS North America Corp. | FIE | Class II | |
| K051660 | Dentronix Dds 7000 Rapid Dry Heat Sterilizer Sterilization System | Coltene /Whaledent AG | KMH | Class II | |
| K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | NEW | Class II |