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 |
|---|---|---|---|---|---|
| K072118 | Stryker Vertaplex Radiopaque Bone Cement | Stryker Corp. | NDN | Class II | |
| K071878 | Delta Scanner, Delta Scanner Pro, Ds Spine Pro, Ds Sports Pro and Ds Rehab | Med-Lectric Corporation | GZJ | Class II | |
| K071164 | Life+cel Battery | Amco International Manufacturing & Design, Inc. | MHX | Class II | |
| K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.c. Temperature-Sensing Foley Catheters | C.R. Bard Inc | EZL | Class II | |
| K070558 | Bardex Lubri-Sil and Bardex Lubri-Sil I.c. Anti-Infective All-Silicone Foley Catheters | C.R. Bard Inc | EZL | Class II | |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317T; Cup Multi Drug Sc | Phamatech Inc. | DIS | Class II | |
| K070021 | Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 | Jg Medical Products, LLC | HRX | Class II | |
| K070009 | At Home Drug Test Models, 9308T and 9308X | Phamatech Inc. | DIS | Class II | |
| K063845 | Advia Chemistry Total Bilirubin_2 | Medrad, Inc. | JFM | Class II | |
| K073151 | Mantis Spinal System | Stryker Corp. | NKB | Class II | |
| K073126 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K073123 | Cardica C-Port Flex-a Distal Anastomosis System, Model Fg-000150 | Cardica, Inc. | FZP | Class II | |
| K072649 | Spi System Dental Implants | Thommen Medical AG | DZE | Class II | |
| K072531 | Legion Stem with Holes | Smith & Nephew, Inc. | JWH | Class II | |
| K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System | Zimmer GmbH | FMF | Class II | |
| K072264 | Fastpack Hcg Immunoassay | Qualigen Inc | JHI | Class II | |
| K071219 | Athena Multi-Lyte Gbm Test System | Zeus Scientific LLC | MVJ | Class II | |
| K071093 | San Shih Powered Muscle Stimulator, Model 202 | San Shih Electrical Enterprise Co., Ltd. | IPF | Class II | |
| K073271 | Orthogon | AGFA Healthcare Corp. | LLZ | Class II | |
| K073141 | Spi Art Abutment | Thommen Medical AG | NHA | Class II | |
| K073125 | Valeo Vbr | Amedica Corp. | MQP | Class II | |
| K072577 | Bisico Impression Silicones & Alginates | Bisico GmbH & CO KG | ELW | Class II | |
| K072558 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model Cn1005 | Cardionet, LLC | QYX | Class II | |
| K073300 | Milesman Premium | Milesman S.L. | GEX | Class II | |
| K072830 | Rm Bond, Model J032 | Pentron Clinical Technologies | DYH | Class II | |
| K072750 | Spectranetics Quick-Cross Support2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | DQY | Class II | |
| K072746 | E-1 Esthetic Composite System | Tokuyama Dental Corporation | EBF | Class II | |
| K072622 | Standout 2 | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K071941 | Memometal Bone Anchors | Memometal Technologies | HWC | Class II | |
| K071795 | Nuvasive Coroent System | NuVasive Inc | MAX | Class II | |
| K071712 | Leuko Ez Vue | Techlab Inc., Corporate Research Center | DEG | Class I | |
| K070757 | Microprotein Reagent Set | Horiba Instruments Incorporated | JGP | Class II | |
| K073170 | R-Port II Laparoscopic Access Device | Advanced Surgical Concepts | GCJ | Class II | |
| K073147 | Sleuth Implantable ECG System-8 Cm Accessory Kit, Model 3000-08 | Transoma Medical | MXC | Class II | |
| K072878 | Modification to: Locator Implant Anchor | Zest Anchors LLC | NHA | Class II | |
| K072453 | Cry-Ac Tracker, Model(s) B-700T, and B-800T | Brymill Corporation | GEH | Class II | |
| K072344 | Apl Medical System | Bios S.r.l. | GEX | Class II | |
| K071697 | Neuronav System and Neuronav Drive | Alpha Omega, Ltd. | GZL | Class II | |
| K070824 | Creatinine (Enzymatic) | Thermofisher Scientific Oy | JFY | Class II | |
| K070053 | Easyplus Mini Self Monitoring Glucose Test System, Models R1 and R2 | Eps Bio Technology Corp. | NBW | Class II | |
| K060846 | Therapeutic Massage Companion | Endurance Therapeutics | NUH | Class II | |
| K073236 | Neocoil 3.0T 32-Channel Torso Array Coil for Ge | NeoCoil, LLC | MOS | Class II | |
| K073100 | Introducer Sets, Models Adelante and Adelante-S | Oscor Inc. | DYB | Class II | |
| K073017 | Stryker Stri-Shield Flyte Togas | Stryker Corp. | FYA | Class II | |
| K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with | Abbott Medical | JKA | Class II | |
| K072325 | Body Composition Analyzer, Easybody 202, 203, 205 | Jawon Medical Co., Ltd. | MNW | Class II | |
| K072115 | Abx Pentra Creatinine 120 Cp, Total Protein 100 Cp, Multical, N and P Controls, and Urine Control L/h | Horiba Abx | CGX | Class II | |
| K071667 | Synthes Vectra-One System | Synthes GmbH | KWQ | Class II | |
| K071265 | Smartcheck Inr System | Inverness Medical Innovations, Inc. | JPA | Class II | |
| K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | Dermaport, Inc. | MSD | Class II |