Cleared Special

K043368 - VITELCARE TURTLE, MODEL 400

K043368 is an FDA 510(k) clearance for VITELCARE TURTLE, manufactured by Visual Telecommunications Network, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 55-day FDA review.

K043368 · Visual Telecommunications Network, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
55d
Days
Class 2
Risk

K043368 is an FDA 510(k) clearance for the VITELCARE TURTLE, MODEL 400. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Visual Telecommunications Network, Inc. (Mclean, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 55 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.

FDA 510(k) Submission Details - K043368

510(k) Number K043368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date February 01, 2005
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K043368.
STAR 50 MONITORING SYSTEM
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HYPERQ SYSTEM
K042981 · Biological Signal Processing, Ltd. · Mar 2005
PLANET 50 MONITORING SYSTEM
K043370 · Larsen & Toubro Limited · Feb 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
INTEGRATED PATIENT MONITORING SYSTEM
K041918 · Invivo Research, Inc. · Oct 2004
STELLAR 404 MONITORING SYSTEM
K042560 · Larsen & Toubro Limited · Oct 2004
K043368 · VITELCARE TURTLE, MODEL 400
Download PDF FDA Summary Visual Telecommunicat…