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THE TAPE

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 / K252306

510(k) cleared

Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100)

Steritec Products · Apr 22, 2026 · K252306

FDA cleared the Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) from Steritec Products on Apr 22, 2026 under K252306, a traditional 510(k). The device falls under product code QVB, Biological Sterilization Indicator With Indirect Growth Detection, regulated at 21 CFR 880.2806 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 24, 2025. The decision came 272 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 Steritec Products in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252306?

K252306 is the FDA 510(k) for Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100), submitted by Steritec Products. FDA's decision date was Apr 22, 2026, under product code QVB (Biological Sterilization Indicator With Indirect Growth Detection).

Who makes the Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100)?

Steritec Products, based in Engelwood, CO, is the applicant of record for K252306.

How long did the K252306 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Apr 22, 2026, 272 days later.

← All decisions in April 2026