Cleared Traditional

K033283 - CENTRA VIEW DEVICE LINK SYSTEM

K033283 is an FDA 510(k) clearance for CENTRA VIEW DEVICE LINK SYSTEM, manufactured by Icu Datasystems, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K033283 · Icu Datasystems, Inc. · Cardiovascular device
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Oct 2003
Decision
13d
Days
Class 2
Risk

K033283 is an FDA 510(k) clearance for the CENTRA VIEW DEVICE LINK SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Icu Datasystems, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 27, 2003 after a review of 13 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icu Datasystems, Inc. devices

FDA 510(k) Submission Details - K033283

510(k) Number K033283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date October 27, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 227
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K033283.
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UNITY NETWORK ID
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