FDA 510(k)

IsoSphere

K-Number: K242818 · 2025-07-15

Decision Date2025-07-15

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IsoSphere is a medical device manufactured by Isoaid, LLC. It received FDA 510(k) clearance on 2025-07-15 under approval number K242818. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IsoSphere?

IsoSphere is a medical device that received FDA 510(k) clearance on 2025-07-15. It is manufactured by Isoaid, LLC. The 510(k) number is K242818.

When was IsoSphere approved by the FDA?

IsoSphere received FDA 510(k) clearance on 2025-07-15, under approval number K242818.

What company makes IsoSphere?

IsoSphere is manufactured by Isoaid, LLC.

What is the FDA product code for IsoSphere?

The FDA product code for IsoSphere is KXK.

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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.