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FDA 510(k)

Oxiplex

K-Number: K253326 · 2026-05-01

ApplicantFziomed, Inc.
Decision Date2026-05-01
Product CodeQVL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Oxiplex is a medical device manufactured by Fziomed, Inc.. It received FDA 510(k) clearance on 2026-05-01 under approval number K253326. The device is classified under product code QVL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxiplex?

Oxiplex is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by Fziomed, Inc.. The 510(k) number is K253326.

When was Oxiplex approved by the FDA?

Oxiplex received FDA 510(k) clearance on 2026-05-01, under approval number K253326.

What company makes Oxiplex?

Oxiplex is manufactured by Fziomed, Inc..

What is the FDA product code for Oxiplex?

The FDA product code for Oxiplex is QVL.

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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