Cleared Traditional

K161240 - Rhythm View Workstation (non-streaming)

K161240 is the FDA 510(k) clearance for Rhythm View Workstation (non-streaming) by Abbott Electrophysiology. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K161240 · Abbott Electrophysiology · Cardiovascular device
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Aug 2016
Decision
100d
Days
Class 2
Risk

K161240 is an FDA 510(k) clearance for the Rhythm View Workstation (non-streaming). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Abbott Electrophysiology (Menlo Park, US). The FDA issued a Cleared decision on August 10, 2016 after a review of 100 days - within the typical 510(k) review window.

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 Abbott Electrophysiology devices

Submission Details

510(k) Number K161240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date August 10, 2016
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 247
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