Cleared Traditional

K944350 - SC 6000/ SC 6000P/ R50

K944350 is the FDA 510(k) clearance for SC 6000/ SC 6000P/ R50 by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K944350 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
216d
Days
Class 2
Risk

K944350 is an FDA 510(k) clearance for the SC 6000/ SC 6000P/ R50. 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 April 10, 1995 after a review of 216 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

Submission Details

510(k) Number K944350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1994
Decision Date April 10, 1995
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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 225
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K944350.
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SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · Siemens Medical Solutions USA, Inc. · Apr 1995
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
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MARQUETTE EAGLE MONITOR
K920790 · Marquette Electronics, Inc. · Apr 1994
SPACELABS MEDICAL PATIENT MONITOR
K930095 · Spacelabs Medical, Inc. · Sep 1993