FDA applicant

23AndMe, Inc.

Mountain View, CA8 decisions2015–20230 recalls

FDA records 8 decisions for 23AndMe, Inc. (Mountain View, CA) from 2015 to 2023: 5 510(k) clearances and 3 De Novo grants. Most are in product codes QAZ (Cancer Predisposition Risk Assessment System) and QDJ (Direct-To-Consumer Access Pharmacogenetic…). Its devices cite 6 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “23AndMe”.

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

How often FDA has decided 23AndMe, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — 23AndMe, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 23AndMe, 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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23AndMe, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?