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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 / June 2026 / K250690

510(k) cleared

Penumbra System (Thunderbolt Aspiration Tubing)

Penumbra, Inc. · Jun 10, 2026 · K250690

FDA cleared the Penumbra System (Thunderbolt Aspiration Tubing) from Penumbra, Inc. on Jun 10, 2026 under K250690, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 7, 2025. The decision came 460 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: K260599 (INDIGO® Aspiration System INDIGO Link), 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 K250690?

K250690 is the FDA 510(k) for Penumbra System (Thunderbolt Aspiration Tubing), submitted by Penumbra, Inc.. FDA's decision date was Jun 10, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Penumbra System (Thunderbolt Aspiration Tubing)?

Penumbra, Inc., based in Alameda, CA, is the applicant of record for K250690.

How long did the K250690 review take?

FDA received the submission on Mar 7, 2025 and issued its decision on Jun 10, 2026, 460 days later.

← All decisions in June 2026