De Novo · Granted
GrantedTeal Wand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teal Health, Inc. · SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Granted on May 9, 2025 as a new device type through De Novo after a 255-day review. 2 later devices descend from it.
- Decided
- May 9, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- SEP
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240045 | Teal Wand | Teal Health, Inc. | 2025 | — |
| +1 | K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek, Inc. | 2026 | — |
| +1 | K260184 | Onclarity™ Self-Collection Kit | Becton, Dickinson and Company | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SEP device
- #1 K260184 Onclarity™ Self-Collection Kitscore 11.1 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K254121 (DNA Genotek, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SEP devicesSEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SEP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SEP
Too few SEP 510(k)s in any year since 2007 to give a median.
Recalls per year · SEP
No recall names SEP since 2007.
Adverse event reports per year · SEP
No MAUDE report names SEP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240045 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240045: Teal Wand.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240045
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026