Cleared Traditional

K904747 - PEI PLAQUE ELECTRODE ARRAY

K904747 is an FDA 510(k) clearance for PEI PLAQUE ELECTRODE ARRAY, manufactured by Prucka Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 355-day FDA review.

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

FDA 510(k) Submission Details - K904747

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.

DRF Device Classification - Class 2, Special Controls

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 141
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K904747.
ARROW QUADPOLAR MAPPING/PACING CATHETER
K911065 · Arrow Intl., Inc. · Jun 1992
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · Daig Corp. · Mar 1992
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · Medtronic Vascular · Nov 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · C.R. Bard, Inc. · May 1991
MODIFIED EPICARDIAL ARRAY
K902228 · C.R. Bard, Inc. · Jul 1990
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · Daig Corp. · Sep 1989