FDA applicant

Guardant Health, Inc.

Redwood City3 decisions2020–20260 recalls

FDA records 3 decisions for Guardant Health, Inc. (Redwood City) from 2020 to 2026: 3 original PMA approvals. Most are in product codes PQP (Next Generation Sequencing Oncology Panel…) and PHP (System, Colorectal Neoplasia, Dna Methylation…). 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, pathology panel, where it files most

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

FDA decisions per year

1in 2024

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

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

See the 510(k) Report

Guardant Health, Inc.

Which product codes does it file in?

What has FDA decided for it lately?