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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 / December 2025 / K250756

510(k) cleared

Pression Wave PRO External Counter-Pulsation System

Pression, Inc. · Dec 22, 2025 · K250756

FDA cleared the Pression Wave PRO External Counter-Pulsation System from Pression, Inc. on Dec 22, 2025 under K250756, a traditional 510(k). The device falls under product code DRN, Device, Counter-Pulsating, External, regulated at 21 CFR 870.5225 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 12, 2025. The decision came 285 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 Pression, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250756?

K250756 is the FDA 510(k) for Pression Wave PRO External Counter-Pulsation System, submitted by Pression, Inc.. FDA's decision date was Dec 22, 2025, under product code DRN (Device, Counter-Pulsating, External).

Who makes the Pression Wave PRO External Counter-Pulsation System?

Pression, Inc., based in Coatesville, PA, is the applicant of record for K250756.

How long did the K250756 review take?

FDA received the submission on Mar 12, 2025 and issued its decision on Dec 22, 2025, 285 days later.

← All decisions in December 2025