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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 / April 2026 / K260184

510(k) cleared

Onclarity Self-Collection Kit

Becton, Dickinson and Company · Apr 2, 2026 · K260184

FDA cleared the Onclarity Self-Collection Kit from Becton, Dickinson and Company on Apr 2, 2026 under K260184, a traditional 510(k). The device falls under product code SEP, Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv 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 Jan 21, 2026. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

Becton, Dickinson and Company has 8 other decisions in the tracker over the last 12 months: K260128 (BD Preset and BD A-Line Arterial Blood Collection Syringes), K252378 (BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube), K252506 (BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder), K252137 (BD Insyte IV Catheter).

Questions & Answers

What did FDA clear under K260184?

K260184 is the FDA 510(k) for Onclarity Self-Collection Kit, submitted by Becton, Dickinson and Company. FDA's decision date was Apr 2, 2026, under product code SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay).

Who makes the Onclarity Self-Collection Kit?

Becton, Dickinson and Company, based in Sparks, MD, is the applicant of record for K260184.

How long did the K260184 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Apr 2, 2026, 71 days later.

← All decisions in April 2026