510(k) Report

FDA applicant

Ancestry Genomics, Inc.

San Francisco, CA2 decisions2020–20200 recalls

FDA records 2 decisions for Ancestry Genomics, Inc. (San Francisco, CA) in 2020: 2 510(k) clearances. Most are in product codes PTA (Genetic Variant Detection And Health Risk…) and OYJ (Dna Specimen Collection, Saliva). Its devices cite 2 predicates, 0 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, immunology panel, where it files most

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

FDA decisions per year

2in 2020

2020: 2
2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ancestry Genomics, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ancestry Genomics, 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?

  • PTAGenetic Variant Detection And Health Risk Assessment System1decision
  • OYJDna Specimen Collection, Saliva1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc. · 2020
  • K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc. · 2020

All 2 as Ancestry Genomics, Inc. →