Cleared Traditional

TigerConnect Alarm Management

K243270 · Tigerconnect · Cardiovascular

Sep 2025

Decision

349d

Days

Class 2

Risk

About This 510(k) Submission

K243270 is an FDA 510(k) clearance for the TigerConnect Alarm Management, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Tigerconnect (Santa Monica, US). The FDA issued a Cleared decision on September 30, 2025, 349 days after receiving the submission on October 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K243270 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 2024
Decision Date	September 30, 2025
Days to Decision	349 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF