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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 / September 2025 / K243795

510(k) cleared

pREBOA-PRO Catheter

Prytime Medical Devices, Inc. · Sep 5, 2025 · K243795

FDA cleared the pREBOA-PRO Catheter from Prytime Medical Devices, Inc. on Sep 5, 2025 under K243795, a traditional 510(k). The device falls under product code MJN, Catheter, Intravascular Occluding, Temporary, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 10, 2024. The decision came 269 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 Prytime Medical Devices, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243795?

K243795 is the FDA 510(k) for pREBOA-PRO Catheter, submitted by Prytime Medical Devices, Inc.. FDA's decision date was Sep 5, 2025, under product code MJN (Catheter, Intravascular Occluding, Temporary).

Who makes the pREBOA-PRO Catheter?

Prytime Medical Devices, Inc., based in Boerne, TX, is the applicant of record for K243795.

How long did the K243795 review take?

FDA received the submission on Dec 10, 2024 and issued its decision on Sep 5, 2025, 269 days later.

← All decisions in September 2025