Cleared Special

K012059 - 8100/8500 VITAL SIGNS MONITOR

K012059 is an FDA 510(k) clearance for 8100/8500 VITAL SIGNS MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 30-day FDA review.

K012059 · Criticare Systems, Inc. · Cardiovascular device
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Aug 2001
Decision
30d
Days
Class 2
Risk

K012059 is an FDA 510(k) clearance for the 8100/8500 VITAL SIGNS MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 30 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K012059

510(k) Number K012059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date August 01, 2001
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 153
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K012059.
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K011578 · Agilent Technologies, Inc. · Jun 2001
M2376A DEVICELINK SYSTEM
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