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 |
|---|---|---|---|---|---|
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | Karl Storz SE & Co. KG | EOQ | Class II | |
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | ResMed Corp | BZD | Class II | |
| K251514 | Overjet CBCT Assist | Overjet | QIH | Class II | |
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | FAS | Class II | |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | |
| K250795 | Purevue™ Fms | Novanta Medical GmbH | HRX | Class II | |
| K250780 | ARTAssistant | Manteia Technologies Co.,Ltd. | QKB | Class II | |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical LLC | ODP | Class II | |
| K250743 | Remvia NightGuard | Remvia, LLC | MQC | Unclassified | |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | PBF | Class II | |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | NPL | Class II | |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | DXH | Class II | |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical LLC | MBI | Class II | |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co.,Ltd | INI | Class II | |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | DQK | Class II | |
| K252126 | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | PAW | Class II | |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | NP Medical | FPA | Class II | |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics Inc. | JNL | Class II | |
| K250791 | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | IYN | Class II | |
| K250679 | FFX Facet Fixation System | SC Medica | MRW | Unclassified | |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph, Inc. | DSH | Class II | |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies Ltd. | QJP | Class II | |
| K251881 | HippoMind (v1.0) | Hippoclinic | OLT | Class II | |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | QJI | Class II | |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | OEB | Class II | |
| K250725 | Hugo™ RAS System | Medtronic, Inc. | SCV | Class II | |
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | JAD | Class II | |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd | FYA | Class II | |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | FBK | Class II | |
| K250896 | Aura Wave | Aura Wellness, LLC | SGT | Class II | |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | Becton Dickinson & Co | NGT | Class II | |
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | DSA | Class II | |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited | OLI | Class II | |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies Inc | DQA | Class II | |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies Inc | DQA | Class II | |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | KPS | Class II | |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. | KWT | Class II | |
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | QDG | Class II | |
| K252658 | Medical Diode Laser Systems (TR-B) | Baoding Te'anzhou Electronic Technology Co.,Ltd. | GEX | Class II | |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | JAK | Class II | |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | JXG | Class II | |
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers Inc | DYW | Class II | |
| K253269 | OEC One CFD | GE Hualun Medical Systems Co., Ltd. | OXO | Class II | |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular | MOF | Class II |