Natera, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Natera, Inc.”, 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 |
|---|---|---|---|
| P260004 | PMA | Signatera CDx | 2026-05-15 |
Recalls
openFDA lists no recalls under a recalling firm named Natera, Inc..
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.
Device clinical trials
An industry sponsor named Natera, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07214532: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (Recruiting, started 2026-03-24)
- NCT06808880: EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND) (Recruiting, started 2024-01-25)
- NCT05170425: LAMBDA 002 (Lung Registry) Study (Active not recruiting, started 2022-11-04)
- NCT05312814: Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management. (Completed, started 2021-10-01)
SEC filings
Natera, Inc. (NTRA): EDGAR filings, CIK 1604821. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Natera, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Natera, Inc.”, 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 Natera, Inc.?
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 Natera, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQP, Natera, Inc.'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.