Teal Health, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Teal Health, Inc.”, plus 1 De Novo 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 |
|---|---|---|---|
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240045 | De Novo | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | 2025-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Teal 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 Teal Health, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06120205: SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening (Active not recruiting, started 2023-11-20)
- NCT05669911: Development of a Self-collection Device for Cervical Cancer Screening (Active not recruiting, started 2022-08-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Teal Health, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Teal Health, Inc.”, plus 1 De Novo 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 Teal Health, Inc.?
The most frequent FDA product codes under this applicant name are SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay, 1).
Next steps
- See all 0 Teal Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SEP, Teal 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.