Cleared Traditional

CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (K980045) - FDA 510(k) Clearance

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

K980045 · Invivo Research, Inc. · Cardiovascular device
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Nov 1998
Decision
314d
Days
Class 2
Risk

K980045 is an FDA 510(k) clearance for the CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Invivo Research, Inc. devices

Submission Details

510(k) Number K980045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date November 16, 1998
Days to Decision 314 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
189d slower than avg
Panel avg: 125d · This submission: 314d
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 107
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K980045.
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K993171 · Hewlett-Packard Co. · Oct 1999
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