Cleared Traditional

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM (K911835) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911835 · Gs Microsystems · Cardiovascular device
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Feb 1992
Decision
295d
Days
Class 2
Risk

K911835 is an FDA 510(k) clearance for the RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Gs Microsystems (Mountain View, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 295 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Gs Microsystems devices

Submission Details

510(k) Number K911835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1991
Decision Date February 14, 1992
Days to Decision 295 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 125d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 96
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K911835.
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