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 |
|---|---|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | CGX | Class II | |
| K251157 | Core Metabolic | Truvian Health | CIX | Class II | |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AB | KPE | Class II | |
| K253784 | 3DICOM MD Cloud | Singular Health Pty Ltd | LLZ | Class II | |
| K253639 | View | GE Healthcare | LLZ | Class II | |
| K253512 | MiniMed Go App | Medtronic, Inc. | NDC | Class II | |
| K253370 | LOGIQ Totus | GE Healthcare | IYN | Class II | |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | MAX | Class II | |
| K252794 | Vision-MR™ Diagnostic Catheter | Imricor Medical Systems | DRF | Class II | |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | TORNIER Inc. | PHX | Class II | |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech Inc | FRO | Unclassified | |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies, LLC | ODP | Class II | |
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | KNG | Class II | |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | DZE | Class II | |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co.,Ltd | FLL | Class II | |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K253939 | DeltaWave Nasal Pillow System | Remsleep Holdings Inc | BZD | Class II | |
| K253924 | PuraStat | 3-D Matrix Europe SAS | QAU | Class II | |
| K253923 | PuraStat | 3-D Matrix Europe SAS | PHN | Unclassified | |
| K253366 | LOGIQ Fortis | GE Healthcare | IYN | Class II | |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise N.V. | PPT | Class II | |
| K253158 | VyBrate™ VBR System | VY Spine, LLC | MQP | Class II | |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | DQA | Class II | |
| K253009 | DS Core Detect | Dentsply Sirona Inc | MYN | Class II | |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical Ltd. | QAS | Class II | |
| K252890 | ZenSeal Pro | Kerr Corporation | KIF | Class II | |
| K252727 | Neodent InLab Validated Workflow | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K252507 | SmileInspector | Amv Consulting, LLC | PNN | Class II | |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | NXC | Class II | |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corp. | QEW | Class II | |
| K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC. | PNE | Class II | |
| K253793 | Materialise TKA Guide System | Materialise N.V. | JWH | Class II | |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed, S.L. | MBI | Class II | |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems LLC | HRS | Class II | |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | ODP | Class II | |
| K252886 | Pen Needle | Hh Global Technology, Inc. | FMI | Class II | |
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | PDJ | Class II | |
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | SGR | Class II | |
| K251097 | V-DAC Catheter | Vesalio | QJP | Class II | |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade Ltd. | PAY | Class II | |
| K253008 | maiLink | maihub Corp. | LLZ | Class II | |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | IYE | Class II | |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | FXX | Class II | |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | FRO | Unclassified | |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding Inc | QJP | Class II | |
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics Inc. | LTJ | Class II | |
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | Zurimed Technologies AG | OWX | Class II | |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | GXP | Class II |