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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 / January 2026 / K250305

510(k) cleared

Reprocessed Agilis NxT Steerable Introducer

Innovative Health · Jan 7, 2026 · K250305

FDA cleared the Reprocessed Agilis NxT Steerable Introducer from Innovative Health on Jan 7, 2026 under K250305, a traditional 510(k). The device falls under product code PNE, Reprocessed Catheter Introducer, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 3, 2025. The decision came 338 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 Innovative Health in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250305?

K250305 is the FDA 510(k) for Reprocessed Agilis NxT Steerable Introducer, submitted by Innovative Health. FDA's decision date was Jan 7, 2026, under product code PNE (Reprocessed Catheter Introducer).

Who makes the Reprocessed Agilis NxT Steerable Introducer?

Innovative Health, based in Scottsdale, AZ, is the applicant of record for K250305.

How long did the K250305 review take?

FDA received the submission on Feb 3, 2025 and issued its decision on Jan 7, 2026, 338 days later.

← All decisions in January 2026