Cleared Traditional

ZYMED TELEMETRY SYSTEM (K980186) - FDA 510(k) Clearance

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

K980186 · Agilent Technologies · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
260d
Days
Class 2
Risk

K980186 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 Agilent Technologies (Camarillo, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 260 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 Agilent Technologies devices

Submission Details

510(k) Number K980186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date October 07, 1998
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 125d · This submission: 260d
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 103
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K980186.
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · Hewlett-Packard Co. · Jan 1999
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
K983980 · Siemens Medical Solutions USA, Inc. · Nov 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632 · Siemens Medical Solutions USA, Inc. · Nov 1998
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
K980429 · Hewlett-Packard Co. · Sep 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730 · Siemens Medical Solutions USA, Inc. · Aug 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698 · Siemens Medical Solutions USA, Inc. · Jul 1998