Cleared Traditional

K911835 - RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM

K911835 is an FDA 510(k) clearance for RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCES..., manufactured by Gs Microsystems. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 295-day FDA review.

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

FDA 510(k) Submission Details - K911835

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.

DSI Device Classification - Class 2, Special Controls

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 311
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K911835.
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K912744 · Nihon Kohden America, Inc. · Dec 1991
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