Cleared Traditional

ZYMED TELEMETRY SYSTEM (K951370) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL T8010

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

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

Submission Details

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.

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 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K951370.
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K952054 · Siemens Medical Solutions USA, Inc. · Jun 1996
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K955059 · Siemens Medical Solutions USA, Inc. · Jun 1996
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
K945944 · Nihon Kohden America, Inc. · Nov 1995
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
K951371 · Siemens Medical Solutions USA, Inc. · Oct 1995
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821 · Hewlett-Packard Co. · Oct 1995
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306 · Siemens Medical Solutions USA, Inc. · Jun 1995