FDA 510(k)

InstaFAN

K-Number: K251542 · 2025-07-18

Decision Date2025-07-18

Product CodeODG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

InstaFAN is a medical device manufactured by Onepass Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-18 under approval number K251542. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstaFAN?

InstaFAN is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by Onepass Medical , Ltd.. The 510(k) number is K251542.

When was InstaFAN approved by the FDA?

InstaFAN received FDA 510(k) clearance on 2025-07-18, under approval number K251542.

What company makes InstaFAN?

InstaFAN is manufactured by Onepass Medical , Ltd..

What is the FDA product code for InstaFAN?

The FDA product code for InstaFAN is ODG.

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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.