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 |
|---|---|---|---|---|---|
| K220505 | Attiva | Italian Engineering SRL | GEI | Class II | |
| K203211 | Insulin syringe with integrated needle DL | Dlp Medical Products, Corp. | FMF | Class II | |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co.,Ltd | FYC | Class II | |
| K223038 | Access Cortisol | Siemens Healthcare Diagnostics Inc. | CGR | Class II | |
| K222685 | NIRA Model 2 | Dermal Photonics Corp | OHS | Class II | |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | CAF | Class II | |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co.,Ltd | CAH | Class II | |
| K223686 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd | FXX | Class II | |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine, LLC | OVD | Class II | |
| K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K222451 | Save Gbr | Dentis Co.,Ltd | NHA | Class II | |
| K230270 | 3M™ VitCal Liner/Base | 3M ESPE Dental Products | EJK | Class II | |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | MUH | Class II | |
| K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K223444 | Powder Free Blue Nitrile Examination Glove | S&S Glove Corporation | LZA | Class I | |
| K223296 | Videa Perio Assist | VideaHealth, Inc. | QIH | Class II | |
| K223169 | Nerivio | Theranica Bio-Electronics Ltd. | QGT | Class II | |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | DJG | Class II | |
| K222398 | Care Team Portal | Vivify Health Inc. | DRG | Class II | |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | LYZ | Class I | |
| K221531 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | ODP | Class II | |
| K222574 | Simparo Anchor Line Fixation System | Simparo, Inc | MBI | Class II | |
| K222570 | COPAL knee moulds | Heraeus Medical GmbH | JWH | Class II | |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | MQB | Class II | |
| K230051 | 14F iSLEEVE™ Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K223876 | SMR Shoulder System | Lima Corporate S.p.A. | MBF | Class II | |
| K223679 | Access AMH | Siemens Healthcare Diagnostics Inc. | PQO | Class II | |
| K223648 | Cook® Spectrum® 2 MRC Central Venous Catheter | Cook Advanced Technologies | FOZ | Class II | |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K223395 | Luna Dental Implant System | Shinhung MST Co., Ltd. | NHA | Class II | |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc | MIB | Class II | |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific Inc. | OWQ | Class II | |
| K222950 | AcuPebble OX100 | Acurable Limited | MNR | Class II | |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | Microlife Intellectual Property GmbH | DXN | Class II | |
| K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | MQV | Class II | |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | DWA | Class II | |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K220996 | Duoblade | Cnc Technologies | GEI | Class II | |
| K220337 | GaiaBone Bioabsorbable Bone Graft | Corliber (Shenzhen) Medical Device Co., Ltd. | MQV | Class II | |
| K220296 | Manta Ray TDF Spacer | SeaSpine Orthopedics Corporation | ODP | Class II | |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | BioFire Diagnostics, LLC | QOF | Class II | |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | Inbios International, Inc. | QUU | Class II | |
| K230012 | Atomica Planner | Atomica Technology, Inc | LLZ | Class II | |
| K223627 | PreView-III™ Anterior Cervical Plate System | Nexus Spine, L.L.C. | KWQ | Class II | |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | MicroAire Surgical Instruments, LLC | HRX | Class II | |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | OVE | Class II | |
| K223284 | SutureLoc™ Implant | Arthrex GmbH | MBI | Class II | |
| K222803 | Oncospace | Oncospace, Inc. | MUJ | Class II |