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FDA 510(k)

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

K-Number: K253033 · 2025-10-21

ApplicantSimplivia Healthcare , Ltd.
Decision Date2025-10-21
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is a medical device manufactured by Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-10-21 under approval number K253033. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by Simplivia Healthcare , Ltd.. The 510(k) number is K253033.

When was Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor approved by the FDA?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor received FDA 510(k) clearance on 2025-10-21, under approval number K253033.

What company makes Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is manufactured by Simplivia Healthcare , Ltd..

What is the FDA product code for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

The FDA product code for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is ONB.

Other Devices by Simplivia Healthcare , Ltd.

K192866Chemfort CSTD K210707OnGuard2 Chemfort Closed Administration (CADM) K201142TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set K231286Chemfort® Catheter Adaptor K251411Chemfort Female Luer Lock Adaptor

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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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