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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 / August 2026 / K262392

510(k) cleared

APRO 35 Swift Catheter

Alembic, LLC · Aug 12, 2026 · K262392

FDA cleared the APRO 35 Swift Catheter from Alembic, LLC on Aug 12, 2026 under K262392, a special 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 14, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Alembic, LLC has one other decision in the tracker over the last 12 months: K262391 (APRO 35 Swift Catheter and Alembic Aspiration Tubing).

Questions & Answers

What did FDA clear under K262392?

K262392 is the FDA 510(k) for APRO 35 Swift Catheter, submitted by Alembic, LLC. FDA's decision date was Aug 12, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the APRO 35 Swift Catheter?

Alembic, LLC, based in Mountain View, CA, is the applicant of record for K262392.

How long did the K262392 review take?

FDA received the submission on Jul 14, 2026 and issued its decision on Aug 12, 2026, 29 days later.

← All decisions in August 2026

Sources