510(k) Report

FDA applicant

Teal Health, Inc.

San Francisco, CA1 decision2025–20250 recalls

FDA records 1 decision for Teal Health, Inc. (San Francisco, CA) in 2025: 1 De Novo grant. All are in product code SEP (Device For Home Collection And Transport Of…). No recall is linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Teal Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Teal Health, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teal Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An…1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN240045Teal WandTeal Health, Inc. · 20252cite it

What has FDA decided for it lately?

The one decision as Teal Health, Inc. →