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 / August 2026 / K260438

510(k) cleared

Vital Signs Monitor (CLEO2)

Infinium Medical, Inc. · Aug 14, 2026 · K260438

FDA cleared the Vital Signs Monitor (CLEO2) from Infinium Medical, Inc. on Aug 14, 2026 under K260438, a traditional 510(k). The device falls under product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 11, 2026. The decision came 184 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 Infinium Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260438?

K260438 is the FDA 510(k) for Vital Signs Monitor (CLEO2), submitted by Infinium Medical, Inc.. FDA's decision date was Aug 14, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the Vital Signs Monitor (CLEO2)?

Infinium Medical, Inc., based in Largo, FL, is the applicant of record for K260438.

How long did the K260438 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Aug 14, 2026, 184 days later.

← All decisions in August 2026