Cleared Traditional

K915632 - PACEART CPTS-86/12

K915632 is an FDA 510(k) clearance for PACEART CPTS-86/12, manufactured by Paceart, Inc.. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K915632 · Paceart, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
119d
Days
Class 2
Risk

K915632 is an FDA 510(k) clearance for the PACEART CPTS-86/12. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Paceart, Inc. (Wayne, US). The FDA issued a Cleared decision on April 14, 1992 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - 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 - K915632

510(k) Number K915632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1991
Decision Date April 14, 1992
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRE Device Classification - Class 2, Special Controls

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 - KRE Analyzer, Pacemaker Generator Function, Indirect

All 7
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K915632.
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