Cleared Traditional

K912938 - RHYTHM

K912938 is an FDA 510(k) clearance for RHYTHM, manufactured by Stellate Systems. The device is a Class 1 Neurology device with product code GWS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K912938 · Stellate Systems · Neurology device
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Jul 1991
Decision
25d
Days
Class 1
Risk

K912938 is an FDA 510(k) clearance for the RHYTHM. Classified as Analyzer, Spectrum, Electroencephalogram Signal (product code GWS), Class I - General Controls.

Submitted by Stellate Systems (Westmount, Quebec, CA). The FDA issued a Cleared decision on July 30, 1991 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1420 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K912938

510(k) Number K912938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date July 30, 1991
Days to Decision 25 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 149d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

GWS Device Classification - Class 1, General Controls

Product Code GWS Analyzer, Spectrum, Electroencephalogram Signal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GWS Analyzer, Spectrum, Electroencephalogram Signal

All 12
Devices cleared under the same product code (GWS) and FDA review panel - the closest regulatory comparables to K912938.
PERSYST PRISM
K974718 · Persyst Development Corp. · Mar 1998
EEG ANALYZER
K925735 · Bio-Scan, Inc. · Dec 1993
NICOLET BEAM II SYSTEM
K894629 · Nicolet Instrument Corp. · Mar 1990
ISTAT SOFTWARE
K871931 · Neuroscience, Inc. · Oct 1987
STD-228 SPECTRAL TREND DISPLAY
K871480 · Grass-Telefactor Product Group · May 1987
OEE_7102 EEG/TREND MONITOR
K854662 · Nihon Kohden America, Inc. · Aug 1986
K912938 · RHYTHM
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