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.

View all Pace Tech, Inc. devices

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 649
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K934385.
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER
K945947 · Nellcor, Inc. · Mar 1995
TRIMLINE 2000
K943081 · Pymah Corp. · Jan 1995
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
K941167 · Spacelabs Medical, Inc. · Nov 1994
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994
EXACTA-SPEZIAL
K925295 · Rudolf Riester GmbH & Co. KG · Mar 1994
PRECISA
K925294 · Rudolf Riester GmbH & Co. KG · Feb 1994