Cleared Special

K001020 - 8100 VITAL SIGNS MONITOR

K001020 is an FDA 510(k) clearance for 8100 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 29-day FDA review.

K001020 · Criticare Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
29d
Days
Class 2
Risk

K001020 is an FDA 510(k) clearance for the 8100 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 April 28, 2000 after a review of 29 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 - K001020

510(k) Number K001020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date April 28, 2000
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K001020.
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K002009 · Agilent Technologies, Inc. · Aug 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · Welch Allyn, Inc. · Jul 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · Agilent Technologies, Inc. · Jun 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
K000635 · Agilent Technologies, Inc. · Mar 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · Critikon Company, LLC · Feb 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · Eastman Kodak Company · Feb 2000