Cleared Traditional

K970348 - SIEMENS SC/9000/SC9015 SERIES SURGICAL ...

K970348 is the FDA 510(k) clearance for SIEMENS SC/9000/SC9015 SERIES SURGICAL ... 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 198-day FDA review.

K970348 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Aug 1997
Decision
198d
Days
Class 2
Risk

K970348 is an FDA 510(k) clearance for the SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER. 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 August 15, 1997 after a review of 198 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 K970348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1997
Decision Date August 15, 1997
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 K970348.
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282 · Spacelabs Medical, Inc. · Sep 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · Siemens Medical Solutions USA, Inc. · Sep 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585 · Fukuda Denshi USA, Inc. · Sep 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920 · Siemens Medical Solutions USA, Inc. · Jul 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · Hewlett-Packard Co. · May 1997