Cleared Traditional

K934385 - MINIPACK 3100/3000 MODIFICATION

K934385 is an FDA 510(k) clearance for MINIPACK 3100/3000 MODIFICATION, manufactured by Pace Tech, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K934385 · Pace Tech, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
335d
Days
Class 2
Risk

K934385 is an FDA 510(k) clearance for the MINIPACK 3100/3000 MODIFICATION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 10, 1994 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

FDA 510(k) Submission Details - K934385

510(k) Number K934385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date August 10, 1994
Days to Decision 335 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
210d slower than avg
Panel avg: 125d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 1054
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K934385.
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
K941167 · Spacelabs Medical, Inc. · Nov 1994
PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM
K942871 · Colin Medical Instruments Corp. · Oct 1994
BIG BEN
K942650 · Rud Riester GmbH & CO KG · Aug 1994
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994
ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR
K940620 · Quality Systems Design, Inc. · Aug 1994
VARIOUS TYPES OF MERCURIALS
K943461 · Rud Riester GmbH & CO KG · Jul 1994
K934385 · MINIPACK 3100/3000 MODIFICATION
Download PDF Pace Tech, Inc.