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FDA 510(k)

Vial2Bag Advanced® 13mm Admixture Device

K-Number: K230988 · 2023-12-01

ApplicantWest Pharma. Services IL, Ltd.
Decision Date2023-12-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial2Bag Advanced® 13mm Admixture Device is a medical device manufactured by West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under approval number K230988. 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® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by West Pharma. Services IL, Ltd.. The 510(k) number is K230988.

When was Vial2Bag Advanced® 13mm Admixture Device approved by the FDA?

Vial2Bag Advanced® 13mm Admixture Device received FDA 510(k) clearance on 2023-12-01, under approval number K230988.

What company makes Vial2Bag Advanced® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is manufactured by West Pharma. Services IL, Ltd..

What is the FDA product code for Vial2Bag Advanced® 13mm Admixture Device?

The FDA product code for Vial2Bag Advanced® 13mm Admixture Device is LHI.

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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)

Other Devices by West Pharma. Services IL, Ltd.

K213513Vented Vial Adapter 20mm K232875Vial Adapter 20mm K230464MixJect® Transfer Device K231071Mix2Vial® Transfer Device

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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.

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