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FDA 510(k)

IsoSphere

K-Number: K242818 · 2025-07-15

ApplicantIsoaid, LLC
Decision Date2025-07-15
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IsoSphere is the device name listed in this FDA 510(k) record. The listed applicant is Isoaid, LLC. It received FDA 510(k) clearance on 2025-07-15 under 510(k) 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. The listed applicant is Isoaid, LLC. The 510(k) number is K242818.

When did IsoSphere receive FDA 510(k) clearance?

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

Who is the listed applicant for IsoSphere?

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

What is the FDA product code for IsoSphere?

The FDA product code for IsoSphere is KXK.

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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

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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