Cleared Special

SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 (K030657) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030657 · Siemens Medical Solutions · Cardiovascular device
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Mar 2003
Decision
18d
Days
Class 2
Risk

K030657 is an FDA 510(k) clearance for the SIEMENS INFINITY GATEWAY SUITE, MODEL VF2. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Siemens Medical Solutions (Danvers, US). The FDA issued a Cleared decision on March 21, 2003 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions devices

Submission Details

510(k) Number K030657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date March 21, 2003
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 161
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K030657.
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K030431 · Ge Medical Systems Information Technologies · Feb 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · Siemens Medical Solutions USA, Inc. · Feb 2003