# DEN240045: Teal Wand

- Pathway: De Novo (Direct)
- Applicant: Teal Health, Inc.
- Decided: May 9, 2025 after 255 days
- Product code: SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay)
- Device class: 2
- Regulation: 21 CFR 866.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K254121: Colli-Pee•Dx Urine Collection Kit (2026), 0 descendants of its own
- K260184: Onclarity™ Self-Collection Kit (2026), 0 descendants of its own

## Indications for use
The Teal Wand is a device for the self-collection of vaginal specimens for the purpose of collecting and transporting specimens for use in an FDA approved HPV molecular assay with which the collection device has been validated. The Teal Wand can be used at-home or in any private setting. Specimens can be collected, stored, and shipped dry in an empty vial.

Source page: https://510kreport.com/device/DEN240045
Methodology: https://510kreport.com/methodology