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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 / K243270

510(k) cleared

TigerConnect Alarm Management

Tigerconnect · Sep 30, 2025 · K243270

FDA cleared the TigerConnect Alarm Management from Tigerconnect on Sep 30, 2025 under K243270, a traditional 510(k). The device falls under product code MSX, System, Network And Communication, Physiological Monitors, regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 16, 2024. The decision came 349 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 Tigerconnect in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243270?

K243270 is the FDA 510(k) for TigerConnect Alarm Management, submitted by Tigerconnect. FDA's decision date was Sep 30, 2025, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the TigerConnect Alarm Management?

Tigerconnect, based in Santa Monica, CA, is the applicant of record for K243270.

How long did the K243270 review take?

FDA received the submission on Oct 16, 2024 and issued its decision on Sep 30, 2025, 349 days later.

← All decisions in September 2025