Cleared Traditional

K951370 - ZYMED TELEMETRY SYSTEM

Also marketed or referenced as:
MODEL T8010

K951370 is an FDA 510(k) clearance for ZYMED TELEMETRY SYSTEM, manufactured by Zymed Medical Instrumentation. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K951370 · Zymed Medical Instrumentation · Cardiovascular device
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Oct 1995
Decision
193d
Days
Class 2
Risk

K951370 is an FDA 510(k) clearance for the ZYMED TELEMETRY SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Zymed Medical Instrumentation (Camarillo, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 193 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 Zymed Medical Instrumentation devices

FDA 510(k) Submission Details - K951370

510(k) Number K951370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date October 06, 1995
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 284
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K951370.
QUEST EXERCISE STRESS SYSTEM
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K945944 · Nihon Kohden America, Inc. · Nov 1995
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K951371 · Siemens Medical Solutions USA, Inc. · Oct 1995
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K950821 · Hewlett-Packard Co. · Oct 1995
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
K952885 · Spacelabs Medical, Inc. · Sep 1995