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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K254121

510(k) cleared

Colli-PeeDx Urine Collection Kit

DNA Genotek, Inc. · Jun 10, 2026 · K254121

FDA cleared the Colli-PeeDx Urine Collection Kit from DNA Genotek, Inc. on Jun 10, 2026 under K254121, a traditional 510(k). The device falls under product code SIH, Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay, regulated at 21 CFR 866.2920 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 19, 2025. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for DNA Genotek, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254121?

K254121 is the FDA 510(k) for Colli-PeeDx Urine Collection Kit, submitted by DNA Genotek, Inc.. FDA's decision date was Jun 10, 2026, under product code SIH (Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay).

Who makes the Colli-PeeDx Urine Collection Kit?

DNA Genotek, Inc., based in Ottawa, is the applicant of record for K254121.

How long did the K254121 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Jun 10, 2026, 173 days later.

← All decisions in June 2026