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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 / K251572

510(k) cleared

eRapid with eTrack System

Pari Respiratory Equipment, Inc. · Dec 19, 2025 · K251572

FDA cleared the eRapid with eTrack System from Pari Respiratory Equipment, Inc. on Dec 19, 2025 under K251572, a traditional 510(k). The device falls under product code CAF, Nebulizer (Direct Patient Interface), regulated at 21 CFR 868.5630 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 22, 2025. The decision came 211 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 Pari Respiratory Equipment, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251572?

K251572 is the FDA 510(k) for eRapid with eTrack System, submitted by Pari Respiratory Equipment, Inc.. FDA's decision date was Dec 19, 2025, under product code CAF (Nebulizer (Direct Patient Interface)).

Who makes the eRapid with eTrack System?

Pari Respiratory Equipment, Inc., based in Midlothian, VA, is the applicant of record for K251572.

How long did the K251572 review take?

FDA received the submission on May 22, 2025 and issued its decision on Dec 19, 2025, 211 days later.

← All decisions in December 2025