Cleared Traditional

K251218 - SafeBeat Rx App

K251218 is an FDA 510(k) clearance for SafeBeat Rx App, manufactured by Safebeat Rx, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K251218 · Safebeat Rx, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
291d
Days
Class 2
Risk

K251218 is an FDA 510(k) clearance for the SafeBeat Rx App. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Safebeat Rx, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 6, 2026 after a review of 291 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Safebeat Rx, Inc. devices

FDA 510(k) Submission Details - K251218

510(k) Number K251218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 125d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 268
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K251218.
CARTO™ 3 EP Navigation System V8.4
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K251591 · Edan Instruments, Inc. · Feb 2026
NorthStar™ Mapping System
K252164 · Imricor Medical Systems · Jan 2026
CARTO™ 3 EP Navigation System V9.0 with PIU Plus
K254085 · Biosense Webster, Inc. · Jan 2026
STAR Apollo™ Mapping System
K253733 · Rhythm AI, Ltd. · Dec 2025