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)

Vial2Bag Advanced 20mm Admixture Device

K-Number: K201415 · 2020-10-21

ApplicantWest Pharmaceutical Services Az, Inc.
Decision Date2020-10-21
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial2Bag Advanced 20mm Admixture Device is a medical device manufactured by West Pharmaceutical Services Az, Inc.. It received FDA 510(k) clearance on 2020-10-21 under approval number K201415. 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 Vial2Bag Advanced 20mm Admixture Device?

Vial2Bag Advanced 20mm Admixture Device is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by West Pharmaceutical Services Az, Inc.. The 510(k) number is K201415.

When was Vial2Bag Advanced 20mm Admixture Device approved by the FDA?

Vial2Bag Advanced 20mm Admixture Device received FDA 510(k) clearance on 2020-10-21, under approval number K201415.

What company makes Vial2Bag Advanced 20mm Admixture Device?

Vial2Bag Advanced 20mm Admixture Device is manufactured by West Pharmaceutical Services Az, Inc..

What is the FDA product code for Vial2Bag Advanced 20mm Admixture Device?

The FDA product code for Vial2Bag Advanced 20mm Admixture Device is LHI.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT06497309 Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning COMPLETED

Related PubMed Literature

PMID: 41832928 Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China. European radiology (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40833550 Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions. Drug safety (2026)

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.

↑