Cleared Traditional

K952065 - PACEART CARDIOVOICE

K952065 is an FDA 510(k) clearance for PACEART CARDIOVOICE, 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 259-day FDA review.

K952065 · Paceart, Inc. · Cardiovascular device
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Jan 1996
Decision
259d
Days
Class 2
Risk

K952065 is an FDA 510(k) clearance for the PACEART CARDIOVOICE. 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 January 16, 1996 after a review of 259 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.

View all Paceart, Inc. devices

FDA 510(k) Submission Details - K952065

510(k) Number K952065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date January 16, 1996
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 136
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K952065.
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LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
K951096 · Instromedix, Inc. · Jan 1996
HEARTHWATCH III(TM)
K945476 · Instromedix, Inc. · Nov 1995
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
K950003 · Instromedix, Inc. · Oct 1995
HEARTCARD CARDIAC EVENT MONITOR
K944362 · Instromedix, Inc. · Sep 1995