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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K253553 | Orion | ResMed Corp | BZD | Class II | |
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | GT Metabolic Solutions, Inc. | SAH | Class II | |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | JAK | Class II | |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy | HIH | Class II | |
| K253004 | Luna 3D | LAP GmbH Laser Applikationen | IYE | Class II | |
| K252575 | Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | FYA | Class II | |
| K261840 | BracePaste Prime Plus | American Orthodontics | DYH | Class II | |
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | DZJ | Class II | |
| K261530 | iiSure Infusion Set | Deka Research & Development Corp. | FPA | Class II | |
| K261522 | BioWave BioWraps | Biowave Corporation | GXY | Class II | |
| K261484 | Tissue Approximation System | TAS Medical Inc | GAR | Class II | |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | MTJ | Unclassified | |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries, LLC. | LZA | Class I | |
| K260780 | HeartFocus | Deski | QJU | Class II | |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Straumann USA, LLC | KCT | Class II | |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group LLC | OHS | Class II | |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | LZA | Class I | |
| K260402 | MeRT System | Wave Neuroscience | SIG | Class II | |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | ITI | Class II | |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd | NFO | Class II | |
| K260116 | CustoMED Viewer | Customed, Inc | LLZ | Class II | |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | KGN | Unclassified | |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | KGN | Unclassified | |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co.,Ltd | INI | Class II | |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd | DXN | Class II | |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | NHA | Class II | |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | KCT | Class II | |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & Co. KG | OCZ | Class II | |
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | PGW | Class II | |
| K261093 | Diafil | Diadent Group International | EBF | Class II | |
| K261002 | Pectus Blu System | Biomet Microfixation | HRS | Class II | |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd | IOR | Class I | |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine | OLO | Class II | |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | EBI | Class II | |
| K260364 | Device 300419 Strip | Geistlich Pharma AG | MQV | Class II | |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | CAF | Class II | |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA | GEI | Class II | |
| K253803 | MILAN System | Lumenis Ltd | GEI | Class II | |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | OrthAlign, Inc. | ONN | Class II | |
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical Inc. | QAU | Class II | |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | Zhejiang Decans Medical Devices Co.,Ltd. | NKG | Class II | |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | JKA | Class II | |
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care Inc. | PHZ | Class II | |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | IPF | Class II | |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | GCJ | Class II | |
| K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | NWA | Class II | |
| K260456 | VI°Port™ Liver Preservation System | Traferox Technologies Inc. | KDN | Class II | |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | QVF | Class II | |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2bones USA, LLC | HWC | Class II | |
| K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II |