Cleared Traditional

K040581 - MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM

K040581 is an FDA 510(k) clearance for MEDVIZERTM VITELCARE PATIENT MONITORING..., manufactured by Vitel Net. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K040581 · Vitel Net · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
84d
Days
Class 2
Risk

K040581 is an FDA 510(k) clearance for the MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Vitel Net (Mclean, US). The FDA issued a Cleared decision on May 27, 2004 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Vitel Net devices

FDA 510(k) Submission Details - K040581

510(k) Number K040581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date May 27, 2004
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 543
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