Cleared Traditional

Athelas Home

K243348 · Athelas, Inc. · Hematology
Feb 2026
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K243348 is an FDA 510(k) clearance for the Athelas Home, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Athelas, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 6, 2026, 466 days after receiving the submission on October 28, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K243348 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2024
Decision Date February 06, 2026
Days to Decision 466 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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