Cleared Traditional

K933624 - VITALMAX 4000

K933624 is the FDA 510(k) clearance for VITALMAX 4000 by Pace Tech, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K933624 · Pace Tech, Inc. · Cardiovascular device
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Jul 1994
Decision
365d
Days
Class 2
Risk

K933624 is an FDA 510(k) clearance for the VITALMAX 4000. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Elevated predicate reliance profile. 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 Pace Tech, Inc. devices

Submission Details

510(k) Number K933624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date July 19, 1994
Days to Decision 365 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 125d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 199
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