Cleared Traditional

K932203 - VITALMAX 530

K932203 is an FDA 510(k) clearance for VITALMAX 530, manufactured by Pace Tech Medical Monitors, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K932203 · Pace Tech Medical Monitors, Inc. · Anesthesiology device
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Jul 1994
Decision
439d
Days
Class 2
Risk

K932203 is an FDA 510(k) clearance for the VITALMAX 530. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Pace Tech Medical Monitors, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Pace Tech Medical Monitors, Inc. devices

FDA 510(k) Submission Details - K932203

510(k) Number K932203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1993
Decision Date July 19, 1994
Days to Decision 439 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 140d · This submission: 439d
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 511
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