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 |
|---|---|---|---|---|---|
| K232095 | SeptiCyte RAPID | Immunexpress, Inc | PRE | Class II | |
| K231825 | Panther TPS | Prowess, Inc. | MUJ | Class II | |
| K231700 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | |
| K231478 | Digital Blood Pressure Monitor (Model: YB-800) | Wenzhou Yosun Medical Technology Co., Ltd. | DXN | Class II | |
| K231447 | Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc | OZI | Class II | |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | DPS | Class II | |
| K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K230926 | Ova+ (K-OVAP-USA) | Tenscare Ltd. | NUH | Class II | |
| K230751 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | QNP | Class II | |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | BZG | Class II | |
| K223721 | Masimo Stork | Masimo Corporation | DQA | Class II | |
| DEN230050 | Body Temperature Software (BTS) | Fitbit LLC | QZA | Class II | |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | KYJ | Class II | |
| K233648 | Millipede 088 Access Catheter | Perfuze | QJP | Class II | |
| K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Co., Inc. | DRE | Class II | |
| K233374 | Secret Pro | Ilooda Co,., Ltd. | GEI | Class II | |
| K233227 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | CBI | Class II | |
| K232455 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | HIF | Class II | |
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | MQS | Class II | |
| K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | HRS | Class II | |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Pte. Ltd. | JOW | Class II | |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | KGE | Class II | |
| K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | QYZ | Class II | |
| K231570 | StrokeViewer Perfusion | NICo-Lab B.V. | LLZ | Class II | |
| K231181 | bright CT | Dentium Co.,Ltd(ict Branch) | OAS | Class II | |
| K230950 | ARTIS icono (VE30A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K223470 | C50 | Sopro | NBL | Class II | |
| K233811 | DT Controlled Phototherapy Equipment | The Daavlin Distributing Co. | FTC | Class II | |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Ortho-Clinical Diagnostics, Inc. | QVF | Class II | |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products Limited | CFN | Class II | |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics Inc. | OBP | Class II | |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | OVE | Class II | |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co.,Ltd | DKZ | Class II | |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System | K&J Consulting Corp. | MRW | Unclassified | |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K232680 | fMRI Hardware System | NordicNeuroLab AS | LNH | Class II | |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | DJG | Class II | |
| K232652 | Anatomical Plating System (various) | Tyber Medical | HRS | Class II | |
| K232572 | Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | OLO | Class II | |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care Inc. | PHZ | Class II | |
| K232231 | QP-Brain® | Quibim S.L. | QIH | Class II | |
| K232077 | Atalante X | Wandercraft | PHL | Class II | |
| K232063 | SaliPen | Saliwell Ltd. | QTT | Class II | |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K231803 | Neodent Implant System - Zirconia Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | ITX | Class II | |
| K231614 | MiroTract Wound Matrix | Reprise Biomedical, Inc. | KGN | Unclassified |