FDA 510(k)

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

K-Number: K253033 · 2025-10-21

Decision Date2025-10-21

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) 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. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K253033.

When did Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor receive FDA 510(k) clearance?

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

Who is the listed applicant for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

The FDA 510(k) record lists Simplivia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Simplivia Healthcare , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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