Cleared Traditional

K002105 - SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

K002105 is an FDA 510(k) clearance for SIEMENS INFINITY SC 6002XL ENHANCED WIT..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K002105 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Dec 2000
Decision
146d
Days
Class 2
Risk

K002105 is an FDA 510(k) clearance for the SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 146 days - within the typical 510(k) review window.

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 - K002105

510(k) Number K002105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2000
Decision Date December 05, 2000
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
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 - MLD Monitor, St Segment With Alarm

All 12
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