Cleared Special

K101602 - VITAL SIGNS MONITOR

K101602 is an FDA 510(k) clearance for VITAL SIGNS MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Special 510(k) pathway after a 85-day FDA review.

K101602 · Criticare Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
85d
Days
Class 2
Risk

K101602 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on September 1, 2010 after a review of 85 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K101602

510(k) Number K101602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2010
Decision Date September 01, 2010
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
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 - MLD Monitor, St Segment With Alarm

All 11
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K101602.
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461 · Philips Medical Systems · Mar 2008
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
K022740 · Datex-Ohmeda · Nov 2002
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · Datex-Ohmeda · Sep 2001
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · Siemens Medical Solutions USA, Inc. · Dec 2000
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · Datex-Ohmeda, Inc. · Nov 1999
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · Medical Data Electronics · Nov 1998