# Athelas, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 3 (2018–2026): 3 510(k) clearances
- Product codes: GKZ (3)
- 510(k) review time since 2016: median 466 days, against 270 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)

## Its most-cited devices
- K181288: Athelas One (2018), cited by 2
- K200828: Athelas Home (2022), cited by 1

## Recent decisions
- K243348: Athelas Home (Feb 6, 2026)
- K200828: Athelas Home (Mar 22, 2022)
- K181288: Athelas One (Nov 5, 2018)

Source page: https://510kreport.com/company/athelas