Cleared Traditional

PEI PLAQUE ELECTRODE ARRAY (K904747) - FDA 510(k) Clearance

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

K904747 · Prucka Engineering, Inc. · Cardiovascular device
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Oct 1991
Decision
355d
Days
Class 2
Risk

K904747 is an FDA 510(k) clearance for the PEI PLAQUE ELECTRODE ARRAY. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Prucka Engineering, Inc. (Houston, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Prucka Engineering, Inc. devices

Submission Details

510(k) Number K904747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date October 09, 1991
Days to Decision 355 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 125d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 50
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K904747.
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K902228 · C.R. Bard, Inc. · Jul 1990
BARD(R) TIP DEFLECTING ELECTRODE CATHETER
K891908 · C.R. Bard, Inc. · Jun 1989