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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 / K251559

510(k) cleared

InstaTRU Instant Biological Indicator for Steam (IBI-05)

True Indicating, LLC · Jun 18, 2026 · K251559

FDA cleared the InstaTRU Instant Biological Indicator for Steam (IBI-05) from True Indicating, LLC on Jun 18, 2026 under K251559, 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 May 21, 2025. The decision came 393 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 True Indicating, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251559?

K251559 is the FDA 510(k) for InstaTRU Instant Biological Indicator for Steam (IBI-05), submitted by True Indicating, LLC. FDA's decision date was Jun 18, 2026, under product code QVB (Biological Sterilization Indicator With Indirect Growth Detection).

Who makes the InstaTRU Instant Biological Indicator for Steam (IBI-05)?

True Indicating, LLC, based in Toledo, OH, is the applicant of record for K251559.

How long did the K251559 review take?

FDA received the submission on May 21, 2025 and issued its decision on Jun 18, 2026, 393 days later.

← All decisions in June 2026