Cleared Traditional

K931296 - PACEART CARDIOPHONE

K931296 is an FDA 510(k) clearance for PACEART CARDIOPHONE, manufactured by Paceart, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K931296 · Paceart, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
185d
Days
Class 2
Risk

K931296 is an FDA 510(k) clearance for the PACEART CARDIOPHONE. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Paceart, Inc. (Wayne, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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.

FDA 510(k) Submission Details - K931296

510(k) Number K931296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date October 01, 1993
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 248
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K931296.
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K932859 · Coherent Systems, Inc. · Feb 1994
CARDIOMAGIC SOFTWARE
K925639 · Instromedix, Inc. · Jun 1993
INSTANT MEMORY 2000
K924187 · Telescan Medical Systems · Jun 1993
CARDIOBEEPER(R) CB-IIA
K925535 · Survival Technology, Inc. · Jan 1993
K931296 · PACEART CARDIOPHONE
Download PDF FDA Summary Paceart, Inc.