510(k) · Cleared
ClearedOnclarity™ Self-Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Cleared on Apr 2, 2026 as substantially equivalent to DEN240045 (Teal Health, Inc., 2025) after a 71-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Apr 2, 2026
- Review
- 71 days
- Class
- Class II
- Product code
- SEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240045 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240045 Teal WandTeal Health, Inc. · 2025
- This deviceK260184 Onclarity™ Self-Collection KitBecton, Dickinson and Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240045 | Teal Wand | Teal Health, Inc. | 2025 | — |
| 0 (this device) | K260184 | Onclarity™ Self-Collection Kit | Becton, Dickinson and Company | 2026 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN240045 | Teal WandSummary page 6…) Product Code(s): SEP Page 1 of 13 Predicate Device Teal Wand (DEN240045) Device Establishment Registration Number: 1119779 Intended Use The Onclarity™ Self-Collection Kit is intended for the self-c… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN240045.
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. 2026, 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 Onclarity™ Self-Collection Kit is intended for the self-collection and transport of vaginal specimens for use with an FDA approved HPV molecular assay with which the collection device has been validated. The Onclarity™ Self-Collection Kit contains all of the necessary components for the self-collection of a vaginal specimen in a home or private setting. Specimen can be collected and shipped dry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260184: Onclarity™ Self-Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260184
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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