Cleared Traditional

SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION (K962970) - FDA 510(k) Clearance

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

K962970 · Spacelabs Medical, Inc. · Cardiovascular device
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Mar 1997
Decision
237d
Days
Class 2
Risk

K962970 is an FDA 510(k) clearance for the SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Redmond, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 237 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 Spacelabs Medical, Inc. devices

Submission Details

510(k) Number K962970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1996
Decision Date March 25, 1997
Days to Decision 237 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
112d slower than avg
Panel avg: 125d · This submission: 237d
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 100
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K962970.
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K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997
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K964832 · Hewlett-Packard Co. · May 1997
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K962291 · Siemens Medical Solutions USA, Inc. · Jan 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · Siemens Medical Solutions USA, Inc. · Jan 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · Hewlett-Packard Co. · Jan 1997