Athelas Home— 510(k) K243348

Name: FDA 510(k) clearance K243348
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Substantially Equivalent

Athelas, Inc.

FDA 510(k) clearance K243348 for Athelas Home, Substantially Equivalent on 2026-02-06. Applicant: Athelas, Inc.. Device class: 2.

Summary

Athelas' Athelas Home is filed under product code GKZ, differential cell counter. The record doesn't describe the device beyond its name and that code name.

Class II, 21 CFR 864.5220. Hematology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Athelas filed from Mountain View, California. FDA found it substantially equivalent 466 calendar days after receipt (October 28, 2024 to February 6, 2026).

Clearance details

Applicant: Athelas, Inc.
Product code: Product code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2024-10-28
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

view all

K260781 — Yumizen H5502026-09-14
K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K251249 — Tru Hematology Test2026-01-16
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

More clearances from Athelas, Inc.

view all

K200828 — Athelas Home2022-03-22
K181288 — Athelas One2018-11-05

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.