510(k) Report

FDA applicant

Caris Life Sciences

Phoenix1 decision2024–20241 recall

FDA records 1 decision for Caris Life Sciences (Phoenix) in 2024: 1 original PMA approval. All are in product code PQP (Next Generation Sequencing Oncology Panel…). 1 recall is linked to its devices.

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

How often FDA has decided Caris Life Sciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Caris Life Sciences by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Caris Life Sciences’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

Which product codes does it file in?

  • PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System1decision

What has FDA decided for it lately?

  • P240010MI Cancer SeekCaris Life Sciences · 20241 recall

The one decision as Caris Life Sciences →

What has been recalled?

1 recall linked to its devices; the latest:

  • P240010MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a…Jun 17, 2025Class II