Caris Life Sciences: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Caris Life Sciences”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240010 | PMA | MI Cancer Seek | 2024-11-05 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-06-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Caris Life Sciences, Inc. (CAI): EDGAR filings, CIK 2019410. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Caris Life Sciences?
FDA lists 0 510(k) clearances under the applicant name “Caris Life Sciences”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Caris Life Sciences?
The most frequent FDA product codes under this applicant name are PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 1).
Next steps
- See all 0 Caris Life Sciences clearances with predicates and recalls
- Run predicate analysis for product code PQP, Caris Life Sciences's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.