Cleared Traditional

K885328 - RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER

K885328 is an FDA 510(k) clearance for RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER, manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Neurology device with product code GYE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K885328 · Telediagnostic Systems, Inc. · Neurology device
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Mar 1989
Decision
84d
Days
Class 2
Risk

K885328 is an FDA 510(k) clearance for the RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1855 - 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.

View all Telediagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K885328

510(k) Number K885328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date March 22, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYE Device Classification - Class 2, Special Controls

Product Code GYE Encephalogram Telemetry System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1855
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 Neurology devices follow this clearance model.

Regulatory Peers - GYE Encephalogram Telemetry System

Devices cleared under the same product code (GYE) and FDA review panel - the closest regulatory comparables to K885328.
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
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K761259 · General Electric Co. · Dec 1976