Cleared Traditional

K033133 - TELECARE D.R. SERVER SOFTWARE SYSTEM

K033133 is an FDA 510(k) clearance for TELECARE D.R. SERVER SOFTWARE SYSTEM, manufactured by Healthcare Vision, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K033133 · Healthcare Vision, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
196d
Days
Class 2
Risk

K033133 is an FDA 510(k) clearance for the TELECARE D.R. SERVER SOFTWARE SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Healthcare Vision, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 13, 2004 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthcare Vision, Inc. devices

FDA 510(k) Submission Details - K033133

510(k) Number K033133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date April 13, 2004
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 154
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K033133.
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · Analogic Corp. · Jul 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · Ge Medical Systems Information Technologies · Jun 2004
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · Philips Medical Systems · Jun 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · Datascope Corp. · Feb 2004
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · Philips Medical Systems · Dec 2003