Cleared Traditional

K972502 - SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496

K972502 is an FDA 510(k) clearance for SPACELABS MEDICAL INTEGRATED MULTIPARAM..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K972502

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
Combination Product No
PCCP Authorized No
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.

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 302
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K972502.
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K980882 · Siemens Medical Solutions USA, Inc. · Jun 1998
CS/3(TM) MONITORS*
K974792 · Datex-Engstrom, Inc. · Jun 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747 · Datex-Engstrom, Inc. · Apr 1998
ENVOY PATIENT MONITOR
K974510 · Mennen Medical, Inc. · Apr 1998