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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 / June 2026 / K260289

510(k) cleared

Perfect-O Ostial Positioning Catheter

Balosmark, Inc. · Jun 5, 2026 · K260289

FDA cleared the Perfect-O Ostial Positioning Catheter from Balosmark, Inc. on Jun 5, 2026 under K260289, a traditional 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 29, 2026. The decision came 127 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 Balosmark, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260289?

K260289 is the FDA 510(k) for Perfect-O Ostial Positioning Catheter, submitted by Balosmark, Inc.. FDA's decision date was Jun 5, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the Perfect-O Ostial Positioning Catheter?

Balosmark, Inc., based in Kalamazoo, MI, is the applicant of record for K260289.

How long did the K260289 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Jun 5, 2026, 127 days later.

← All decisions in June 2026