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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 / K260754

510(k) cleared

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test

Assure Tech., LLC · Jun 5, 2026 · K260754

FDA cleared the Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test from Assure Tech., LLC on Jun 5, 2026 under K260754, a traditional 510(k). The device falls under product code QYT, Over-The-Counter Covid-19 Antigen Test, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 9, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Assure Tech., LLC has one other decision in the tracker over the last 12 months: K261984 (AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup).

Questions & Answers

What did FDA clear under K260754?

K260754 is the FDA 510(k) for Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test, submitted by Assure Tech., LLC. FDA's decision date was Jun 5, 2026, under product code QYT (Over-The-Counter Covid-19 Antigen Test).

Who makes the Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test?

Assure Tech., LLC, based in Wilmington, DE, is the applicant of record for K260754.

How long did the K260754 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Jun 5, 2026, 88 days later.

← All decisions in June 2026

Sources