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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K192875 | Philips Biosensor BX100 | Philips North America LLC | DRG | Class II | |
| DEN190028 | MyCare Psychiatry Clozapine Assay Kit | Saladax Biomedical, Inc. | QKT | Class II | |
| K200887 | As-10 | Canon, Inc. | OWB | Class II | |
| K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident SRL | MUH | Class II | |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corp. | MAX | Class II | |
| K200500 | Molekule Air Pro RX | Molekule, Inc. | FRA | Class II | |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K200092 | 3MTM AttestTM Mini Auto-reader 490M | 3M Company | FRC | Class II | |
| K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | FRG | Class II | |
| K193534 | Monarch Platform | Auris Health, Inc | EOQ | Class II | |
| K193373 | Comprehensive® Reverse Shoulder | Zimmer GmbH | PHX | Class II | |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular | PNO | Class II | |
| K192588 | G-EYE System | Smart Medical Systems Ltd. | FDF | Class II | |
| K191930 | 7 mm Extended Length Endoscope | Maquet Cardiovascular LLC | GCJ | Class II | |
| K200703 | JiveX | Visus Health IT GmbH | LLZ | Class II | |
| K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | GA Health Company Limited | OCX | Class II | |
| K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | LLZ | Class II | |
| K193363 | Dermapose Refresh | Puregraft, LLC | MUU | Class II | |
| K193349 | Vapocoolshot Mist | Vapocoolshot, Inc | MLY | Unclassified | |
| K192982 | KY Grosz UltraGel | Rb Health (Us), LLC | NUC | Class II | |
| K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract Inc | KCT | Class II | |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | JDW | Class II | |
| K191654 | SILICONE Personal Lubricant | Bath Concept Cosmetics (Dongguan) Co., Ltd. | NUC | Class II | |
| K191353 | COMET Lumbar Interbody Fusion Cage | Baui Biotech Co., Ltd. | MAX | Class II | |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | |
| K200726 | AcuityPDR | RadmediX, LLC | IZL | Class II | |
| K200300 | VivAer Stylus | Aerin Medical, Inc. | GEI | Class II | |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | DHX | Class II | |
| K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co.,Ltd | DZE | Class II | |
| K193464 | ND:YAG Laser | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Spectrum Medical Inc | KFM | Class II | |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical Inc | DWA | Class II | |
| K192167 | CuraRad-ICH | Curacloud Corp. | QAS | Class II | |
| K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | ONN | Class II | |
| K193275 | Nerve and Muscle Stimulator | Shenzhen XFT Medical Limited | IPF | Class II | |
| K200668 | DR-ID 1200SDK System | FUJIFILM Corporation | MQB | Class II | |
| K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K200642 | OrthAlign Plus System | OrthAlign, Inc. | OLO | Class II | |
| K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | LZO | Class II | |
| K200078 | VARO Plan | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | |
| K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid | Kimberly-Clark Corporation | LZA | Class I | |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | QAI | Class II | |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | Molnlycke Health Care, US LLC | KGO | Class I | |
| K193282 | SIGNA Premier | GE Healthcare (GE Medical Systems, LLC) | LNH | Class II | |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | Gemtier Medical (Shanghai) Inc. | MEG | Class II | |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | PLC | Class II | |
| K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | LLZ | Class II |