Cleared Traditional

SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 (K972502) - FDA 510(k) Clearance

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

K972502 · Spacelabs Medical, Inc. · Cardiovascular device
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May 1998
Decision
329d
Days
Class 2
Risk

K972502 is an FDA 510(k) clearance for the SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496. 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 May 28, 1998 after a review of 329 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 Spacelabs Medical, Inc. devices

Submission Details

510(k) Number K972502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date May 28, 1998
Days to Decision 329 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
204d slower than avg
Panel avg: 125d · This submission: 329d
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 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K972502.
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
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882 · Siemens Medical Solutions USA, Inc. · Jun 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · Siemens Medical Solutions USA, Inc. · Oct 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · Siemens Medical Solutions USA, Inc. · Sep 1997