# K181288: Athelas One

- Pathway: 510(k) (Traditional)
- Applicant: Athelas, Inc.
- Decided: Nov 5, 2018 after 173 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040073 (2004). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071967: Sysmex XE-5000, Sysmex America, Inc. (2007) Summary page 4.

## Most influential descendants
- K200828: Athelas Home (2022), 1 descendant of its own
- K243348: Athelas Home (2026), 0 descendants of its own

## Indications for use
Athelas One is indicated for use for quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary or K2EDTA venous whole blood. The Athelas One system is for In Vitro Diagnostic use only. The Athelas One is only to be used with Athelas One Test Strips. The Athelas One is indicated for use in clinical laboratories and for point of care settings. The Athelas One is only indicated for use in adult populations (aged 21 and older).

Source page: https://510kreport.com/device/K181288
Methodology: https://510kreport.com/methodology