Cleared Traditional

K962404 - SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM

K962404 is an FDA 510(k) clearance for SIEMENS SC 6000 & SC 6000 P PORTABLE BE..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K962404 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Jan 1997
Decision
210d
Days
Class 2
Risk

K962404 is an FDA 510(k) clearance for the SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 210 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K962404

510(k) Number K962404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date January 17, 1997
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K962404.
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
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BRENTWOOD PC-ECG
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HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · Hewlett-Packard Co. · Jan 1997
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
K961165 · Hewlett-Packard Co. · Oct 1996
EAGLE PATIENT MONITOR
K960418 · Marquette Electronics, Inc. · Oct 1996