Cleared Traditional

PACIFIC COMMUNICATIONS MODEL 1100 (K942147) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942147 · Accucore, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
272d
Days
Class 2
Risk

K942147 is an FDA 510(k) clearance for the PACIFIC COMMUNICATIONS MODEL 1100. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Accucore, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 272 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 Accucore, Inc. devices

Submission Details

510(k) Number K942147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date January 30, 1995
Days to Decision 272 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
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K942147.
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · Siemens Medical Solutions USA, Inc. · May 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · Siemens Medical Solutions USA, Inc. · Apr 1995
SC 6000/ SC 6000P/ R50
K944350 · Siemens Medical Solutions USA, Inc. · Apr 1995
CC ARHYTHMIS MONITORING OPTION
K923747 · Hewlett-Packard Co. · Jul 1993
BSM-8800A BEDSIDE MONITOR
K920154 · Nihon Kohden America, Inc. · Dec 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743 · Nihon Kohden America, Inc. · Sep 1992