Cleared Traditional

K912835 - MINI-PACK 911 SERIES

K912835 is the FDA 510(k) clearance for MINI-PACK 911 SERIES by Pace Tech, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K912835 · Pace Tech, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
222d
Days
Class 2
Risk

K912835 is an FDA 510(k) clearance for the MINI-PACK 911 SERIES. 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 February 3, 1992 after a review of 222 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 K912835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date February 03, 1992
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 125d · This submission: 222d
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
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K912835.
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MONARCH SYSTEM
K911051 · Baxter Healthcare Corp · Aug 1991