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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 / January 2026 / K251357

510(k) cleared

Esperance pHLO Aspiration System

Phenox, Ltd. · Jan 15, 2026 · K251357

FDA cleared the Esperance pHLO Aspiration System from Phenox, Ltd. on Jan 15, 2026 under K251357, 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 Apr 30, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Phenox, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251357?

K251357 is the FDA 510(k) for Esperance pHLO Aspiration System, submitted by Phenox, Ltd.. FDA's decision date was Jan 15, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Esperance pHLO Aspiration System?

Phenox, Ltd., based in Galway, is the applicant of record for K251357.

How long did the K251357 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Jan 15, 2026, 260 days later.

← All decisions in January 2026