510(k) Report

FDA applicant

Natera, Inc.

Austin1 decision2026–20260 recalls

FDA records 1 decision for Natera, Inc. (Austin) in 2026: 1 original PMA approval. All are in product code PQP (Next Generation Sequencing Oncology Panel…). 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 Natera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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