Cleared Traditional

K935043 - SIEMENS CLINICAL WORK STATION

K935043 is the FDA 510(k) clearance for SIEMENS CLINICAL WORK STATION by Siemens Medical Electronics. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 533-day FDA review.

K935043 · Siemens Medical Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
533d
Days
Class 2
Risk

K935043 is an FDA 510(k) clearance for the SIEMENS CLINICAL WORK STATION. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Siemens Medical Electronics (Danvers, US). The FDA issued a Cleared decision on April 7, 1995 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Siemens Medical Electronics devices

Submission Details

510(k) Number K935043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date April 07, 1995
Days to Decision 533 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
408d slower than avg
Panel avg: 125d · This submission: 533d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 231
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