FDA applicant

Tempus Labs, Inc.

Chicago1 decision2023–20230 recalls

FDA records 1 decision for Tempus Labs, Inc. (Chicago) in 2023: 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 Tempus Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Tempus Labs, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tempus Labs, 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

Other applicant names beginning “Tempus”

FDA records each applicant name separately; these may or may not be the same firm.

Tempus AI, Inc. 5

Tempus Labs, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tempus”