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FDA 510(k)

Athelas Home

K-Number: K243348 · 2026-02-06

ApplicantAthelas, Inc.
Decision Date2026-02-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Athelas Home is a medical device manufactured by Athelas, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K243348. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athelas Home?

Athelas Home is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Athelas, Inc.. The 510(k) number is K243348.

When was Athelas Home approved by the FDA?

Athelas Home received FDA 510(k) clearance on 2026-02-06, under approval number K243348.

What company makes Athelas Home?

Athelas Home is manufactured by Athelas, Inc..

What is the FDA product code for Athelas Home?

The FDA product code for Athelas Home is GKZ.

Other Devices by Athelas, Inc.

K181288Athelas One K200828Athelas Home

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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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