Cleared Traditional

K945385 - VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300

K945385 is an FDA 510(k) clearance for VITALMAX 800 PLUS/VITALMAX 810 PLUS/MIN..., manufactured by Pace Tech, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K945385 · Pace Tech, Inc. · Cardiovascular device
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Jan 1995
Decision
89d
Days
Class 2
Risk

K945385 is an FDA 510(k) clearance for the VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300. 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 January 31, 1995 after a review of 89 days - a notably fast clearance cycle.

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: 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 Pace Tech, Inc. devices

FDA 510(k) Submission Details - K945385

510(k) Number K945385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date January 31, 1995
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 351
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K945385.
PARAMETERS MONITORES
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SCHOLAR PATIENT MONITOR
K944860 · Criticare Systems, Inc. · Jun 1995
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K942700 · Critikon Company, LLC · Mar 1995
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994
VITALMAX 4000
K933624 · Pace Tech, Inc. · Jul 1994
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · Hewlett-Packard Co. · Apr 1993