Cleared Traditional

K902228 - MODIFIED EPICARDIAL ARRAY

K902228 is an FDA 510(k) clearance for MODIFIED EPICARDIAL ARRAY, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K902228 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1990
Decision
50d
Days
Class 2
Risk

K902228 is an FDA 510(k) clearance for the MODIFIED EPICARDIAL ARRAY. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on July 6, 1990 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902228

510(k) Number K902228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1990
Decision Date July 06, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
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 185
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K902228.
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
K905831 · Arzco Medical Electronics, Inc. · Mar 1991
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER
K903136 · Arzco Medical Electronics, Inc. · Jan 1991
FRANZ(TM) STEERABLE COMBINATION CATHETER
K903880 · Ep Technologies, Inc. · Oct 1990
STEEROCATH(TM)
K900765 · Ep Technologies, Inc. · May 1990
QUATTRO CATHETER
K900452 · Ep Technologies, Inc. · Mar 1990
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
K895916 · Prucka Engineering, Inc. · Dec 1989
K902228 · MODIFIED EPICARDIAL ARRAY
Download PDF C.R. Bard, Inc.