Guardant Health, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Guardant Health, Inc.”, plus 3 PMA decisions, across 2 product codes 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 | 2 | 0 |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | 1 | 0 |
Review panels
- Pathology (3)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250027 | PMA | Guardant360® Liquid CDx | 2026-05-19 |
| P230009 | PMA | Shield | 2024-07-26 |
| P200010 | PMA | Guardant360 CDx | 2020-08-07 |
Recalls
openFDA lists no recalls under a recalling firm named Guardant Health, 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 Guardant Health, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05935384: SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation (Recruiting, started 2023-10-25)
- NCT05117840: Screening for High Frequency Malignant Disease (Active not recruiting, started 2022-01-13)
SEC filings
Guardant Health, Inc. (GH): EDGAR filings, CIK 1576280. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Guardant Health, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Guardant Health, Inc.”, plus 3 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Guardant Health, Inc.?
The most frequent FDA product codes under this applicant name are PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 2); PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection, 1).
Next steps
- See all 0 Guardant Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQP, Guardant Health, 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.