Cleared Traditional

ESCORT LINK CENTRAL STATION MONITOR (K970012) - FDA 510(k) Clearance

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

K970012 · Medical Data Electronics · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
175d
Days
Class 2
Risk

K970012 is an FDA 510(k) clearance for the ESCORT LINK CENTRAL STATION MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 175 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.

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Submission Details

510(k) Number K970012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1997
Decision Date June 26, 1997
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 K970012.
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K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · Hewlett-Packard Co. · May 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291 · Siemens Medical Solutions USA, Inc. · Jan 1997