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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 / July 2026 / K253277

510(k) cleared

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

Ge Medical Systems Information Technologies, Inc. · Jul 24, 2026 · K253277

FDA cleared the Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P from Ge Medical Systems Information Technologies, Inc. on Jul 24, 2026 under K253277, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 29, 2025. The decision came 298 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ge Medical Systems Information Technologies, Inc. has one other decision in the tracker over the last 12 months: K251670 (MAC 7 Resting ECG Analysis System).

Questions & Answers

What did FDA clear under K253277?

K253277 is the FDA 510(k) for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P, submitted by Ge Medical Systems Information Technologies, Inc.. FDA's decision date was Jul 24, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

Ge Medical Systems Information Technologies, Inc., based in Wauwatosa, WI, is the applicant of record for K253277.

How long did the K253277 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jul 24, 2026, 298 days later.

← All decisions in July 2026

Sources