Cleared Special

K012171 - MODIFICATION TO: ARGUS SYSTEM-CONTINUOU...

K012171 is an FDA 510(k) clearance for MODIFICATION TO: ARGUS SYSTEM-CONTINUOU..., manufactured by Visicu, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Special 510(k) pathway after a 12-day FDA review.

K012171 · Visicu, Inc. · Cardiovascular device
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Jul 2001
Decision
12d
Days
Class 2
Risk

K012171 is an FDA 510(k) clearance for the MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Visicu, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 24, 2001 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Visicu, Inc. devices

FDA 510(k) Submission Details - K012171

510(k) Number K012171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date July 24, 2001
Days to Decision 12 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 74
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K012171.
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K012531 · Datex-Ohmeda · Nov 2001
DATEX-OHMEDA NETWORK AND CENTRAL
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