Cleared Traditional

K980186 - ZYMED TELEMETRY SYSTEM

K980186 is an FDA 510(k) clearance for ZYMED TELEMETRY SYSTEM, manufactured by Agilent Technologies. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K980186 · Agilent Technologies · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K980186

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
Combination Product No
PCCP Authorized No
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.

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 274
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K980186.
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K980045 · Invivo Research, Inc. · Nov 1998
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
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697 · Mennen Medical, Inc. · Aug 1998