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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 / K251949

510(k) cleared

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

Penumbra, Inc. · Feb 5, 2026 · K251949

FDA cleared the INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK from Penumbra, Inc. on Feb 5, 2026 under K251949, 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 Jun 25, 2025. The decision came 225 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Penumbra, Inc. has 3 other decisions in the tracker over the last 12 months: K250690 (Penumbra System (Thunderbolt Aspiration Tubing)), K260599 (INDIGO® Aspiration System INDIGO Link), K252612 (INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing).

Questions & Answers

What did FDA clear under K251949?

K251949 is the FDA 510(k) for INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK, submitted by Penumbra, Inc.. FDA's decision date was Feb 5, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK?

Penumbra, Inc., based in Alameda, CA, is the applicant of record for K251949.

How long did the K251949 review take?

FDA received the submission on Jun 25, 2025 and issued its decision on Feb 5, 2026, 225 days later.

← All decisions in February 2026

Sources