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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 / February 2026 / K260181

510(k) cleared

LF Process Indicator Tape for Steam Sterilization

Intertape Polymer Group · Feb 20, 2026 · K260181

FDA cleared the LF Process Indicator Tape for Steam Sterilization from Intertape Polymer Group on Feb 20, 2026 under K260181, a special 510(k). The device falls under product code JOJ, Indicator, Physical/Chemical Sterilization Process, regulated at 21 CFR 880.2800 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 21, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Intertape Polymer Group in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260181?

K260181 is the FDA 510(k) for LF Process Indicator Tape for Steam Sterilization, submitted by Intertape Polymer Group. FDA's decision date was Feb 20, 2026, under product code JOJ (Indicator, Physical/Chemical Sterilization Process).

Who makes the LF Process Indicator Tape for Steam Sterilization?

Intertape Polymer Group, based in Sarasota, FL, is the applicant of record for K260181.

How long did the K260181 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Feb 20, 2026, 30 days later.

← All decisions in February 2026