510(k) · Cleared
ClearedColli-Pee•Dx Urine Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DNA Genotek, Inc. · SIH Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
Cleared on Jun 10, 2026 as substantially equivalent to DEN240045 (Teal Health, Inc., 2025) after a 173-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Jun 10, 2026
- Review
- 173 days
- Class
- Class II
- Product code
- SIH
- 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 deviceK254121 Colli-Pee•Dx Urine Collection KitDNA Genotek, Inc. · 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) | K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek, Inc. | 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 SIH? 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 5…transport of specimens by lay users for use in a cleared non-viral STI molecular assay) Predicate Device: Teal Wand (DEN240045) Regulation: 21 CFR 866.2920 (Device for home collection and… | 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 SIH devicesSIH Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti 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 · SIH
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIH
Too few SIH 510(k)s in any year since 2007 to give a median.
Recalls per year · SIH
No recall names SIH since 2007.
Adverse event reports per year · SIH
No MAUDE report names SIH 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 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Colli-Pee™ •Dx Urine Collection Kit is a device for the self-collection of first-void urine for the purpose of collecting and transporting specimens for use in an FDA cleared STI molecular assay with which the device has been validated. Colli-Pee™•Dx Urine Collection Kit can be used at-home or in any private setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254121: Colli-Pee•Dx Urine Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254121
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026