Cleared Traditional

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD (K935371) - FDA 510(k) Clearance

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

K935371 · R2 Medical Systems · Cardiovascular device
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Dec 1994
Decision
389d
Days
Class 2
Risk

K935371 is an FDA 510(k) clearance for the R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by R2 Medical Systems (Niles, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 R2 Medical Systems devices

Submission Details

510(k) Number K935371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date December 02, 1994
Days to Decision 389 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
264d slower than avg
Panel avg: 125d · This submission: 389d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 23
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K935371.
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989