Cleared Traditional

K914838 - PROPAQ 102,104,106,102EL,104EL,&106EL

K914838 is an FDA 510(k) clearance for PROPAQ 102, manufactured by Protocol Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K914838 · Protocol Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
77d
Days
Class 2
Risk

K914838 is an FDA 510(k) clearance for the PROPAQ 102,104,106,102EL,104EL,&106EL. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Protocol Systems, Inc. (Beaverton, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 77 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 Protocol Systems, Inc. devices

FDA 510(k) Submission Details - K914838

510(k) Number K914838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date January 10, 1992
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K914838.
MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
K921014 · Hewlett-Packard Co. · Oct 1992
NGM ESTP MODULE
K911646 · Datex Division Instrumentarium Corp. · Feb 1992
MINI-PACK 911 SERIES
K912835 · Pace Tech, Inc. · Feb 1992
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
K912188 · Critikon Company, LLC · Dec 1991
VITALMAX 830 SERIES
K913263 · Pace Tech, Inc. · Oct 1991
MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
K912627 · Ppg Industries, Inc. · Sep 1991