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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 / April 2026 / K260599

510(k) cleared

INDIGO® Aspiration System INDIGO Link

Penumbra, Inc. · Apr 24, 2026 · K260599

FDA cleared the INDIGO® Aspiration System INDIGO Link from Penumbra, Inc. on Apr 24, 2026 under K260599, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 24, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Penumbra, Inc. has 3 other decisions in the tracker over the last 12 months: K250690 (Penumbra System (Thunderbolt Aspiration Tubing)), K251949 (INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK), K252612 (INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing).

Questions & Answers

What did FDA clear under K260599?

K260599 is the FDA 510(k) for INDIGO® Aspiration System INDIGO Link, submitted by Penumbra, Inc.. FDA's decision date was Apr 24, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the INDIGO® Aspiration System INDIGO Link?

Penumbra, Inc., based in Alameda, CA, is the applicant of record for K260599.

How long did the K260599 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Apr 24, 2026, 59 days later.

← All decisions in April 2026