510(k) Report

FDA applicant

Athelas, Inc.

Mountain View, CA3 decisions2018–20260 recalls

FDA records 3 decisions for Athelas, Inc. (Mountain View, CA) from 2018 to 2026: 3 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Since 2016 its 510(k)s took a median of 466 days from receipt to decision, against 270 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Athelas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12022: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Athelas, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Athelas, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GKZCounter, Differential Cell3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 466 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 270 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181288Athelas OneAthelas, Inc. · 20182cite it
  • K200828Athelas HomeAthelas, Inc. · 20221cites it

What has FDA decided for it lately?

  • K243348Athelas HomeAthelas, Inc. · 2026
  • K200828Athelas HomeAthelas, Inc. · 2022
  • K181288Athelas OneAthelas, Inc. · 2018

All 3 as Athelas, Inc. →