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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 / K252204

510(k) cleared

prolaio eVO2peak Module (Version 1.0)

Prolaio, Inc. · Dec 16, 2025 · K252204

FDA cleared the prolaio eVO2peak Module (Version 1.0) from Prolaio, Inc. on Dec 16, 2025 under K252204, a traditional 510(k). The device falls under product code PPW, Adjunctive Cardiovascular Status Indicator, regulated at 21 CFR 870.2200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 14, 2025. The decision came 155 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 Prolaio, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252204?

K252204 is the FDA 510(k) for prolaio eVO2peak Module (Version 1.0), submitted by Prolaio, Inc.. FDA's decision date was Dec 16, 2025, under product code PPW (Adjunctive Cardiovascular Status Indicator).

Who makes the prolaio eVO2peak Module (Version 1.0)?

Prolaio, Inc., based in Chicago, IL, is the applicant of record for K252204.

How long did the K252204 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Dec 16, 2025, 155 days later.

← All decisions in December 2025