Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FlowArt® Vial Access Device Vented

K-Number: K251715 · 2025-10-14

ApplicantAsset Medikal
Decision Date2025-10-14
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FlowArt® Vial Access Device Vented is a medical device manufactured by Asset Medikal. It received FDA 510(k) clearance on 2025-10-14 under approval number K251715. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowArt® Vial Access Device Vented?

FlowArt® Vial Access Device Vented is a medical device that received FDA 510(k) clearance on 2025-10-14. It is manufactured by Asset Medikal. The 510(k) number is K251715.

When was FlowArt® Vial Access Device Vented approved by the FDA?

FlowArt® Vial Access Device Vented received FDA 510(k) clearance on 2025-10-14, under approval number K251715.

What company makes FlowArt® Vial Access Device Vented?

FlowArt® Vial Access Device Vented is manufactured by Asset Medikal.

What is the FDA product code for FlowArt® Vial Access Device Vented?

The FDA product code for FlowArt® Vial Access Device Vented is LHI.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT02438904 Compassionate Access of the Miltenyi Device for CD34+ Cell Selection RECRUITING NCT07110337 Diagnosing Epilepsy To EffeCT Change RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING

Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 40444060 Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union. Frontiers in medical technology (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 39834141 Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing. JMIR human factors (2025)

Related Devices (Code: LHI)

K161800OnSite-IVPharmc, LLC K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. K162216GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. K171796Vial Adapter 15mmMedimop Medical Project , Ltd. K172884Arisure Closed Vial AdapterYukon Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑