WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K252792

510(k) cleared

PM2 System with ECGuide Connector

Piccolo Medical, Inc. · Nov 17, 2025 · K252792

FDA cleared the PM2 System with ECGuide Connector from Piccolo Medical, Inc. on Nov 17, 2025 under K252792, a special 510(k). The device falls under product code LJS, Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, regulated at 21 CFR 880.5970 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 2, 2025. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Piccolo Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252792?

K252792 is the FDA 510(k) for PM2 System with ECGuide Connector, submitted by Piccolo Medical, Inc.. FDA's decision date was Nov 17, 2025, under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).

Who makes the PM2 System with ECGuide Connector?

Piccolo Medical, Inc., based in San Francisco, CA, is the applicant of record for K252792.

How long did the K252792 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Nov 17, 2025, 76 days later.

← All decisions in November 2025