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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 / October 2025 / K252612

510(k) cleared

INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing

Penumbra, Inc. · Oct 16, 2025 · K252612

FDA cleared the INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing from Penumbra, Inc. on Oct 16, 2025 under K252612, 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 Aug 19, 2025. The decision came 58 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)), K260599 (INDIGO® Aspiration System INDIGO Link), K251949 (INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK).

Questions & Answers

What did FDA clear under K252612?

K252612 is the FDA 510(k) for INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing, submitted by Penumbra, Inc.. FDA's decision date was Oct 16, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing?

Penumbra, Inc., based in Alameda, CA, is the applicant of record for K252612.

How long did the K252612 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Oct 16, 2025, 58 days later.

← All decisions in October 2025

Sources