Cleared Special

8600 VITAL SIGNS MONITOR (K042569) - FDA 510(k) Clearance

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

K042569 · Criticare Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
8d
Days
Class 2
Risk

K042569 is an FDA 510(k) clearance for the 8600 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 September 29, 2004 after a review of 8 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

Submission Details

510(k) Number K042569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date September 29, 2004
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 112
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K042569.
TRIO MONITOR
K051897 · Datascope Corp. · Aug 2005
UNITY NETWORK ID
K051518 · Ge Medical Systems Information Technologies · Jul 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
TRIO MONITOR
K041907 · Datascope Corp. · Jul 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · Ge Medical Systems Information Technologies · Jun 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · Datascope Corp. · Feb 2004