Cleared Traditional

SafeBeat Rx App

K251218 · Safebeat Rx, Inc. · Cardiovascular
Feb 2026
Decision
291d
Days
Class 2
Risk

About This 510(k) Submission

K251218 is an FDA 510(k) clearance for the SafeBeat Rx App, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Safebeat Rx, Inc. (San Rafael, US). The FDA issued a Cleared decision on February 6, 2026, 291 days after receiving the submission on April 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K251218 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2025
Decision Date February 06, 2026
Days to Decision 291 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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