Cleared Traditional

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (K800930) - FDA 510(k) Clearance

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

K800930 · R2 Corp. · Cardiovascular device
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May 1980
Decision
32d
Days
Class 2
Risk

K800930 is an FDA 510(k) clearance for the R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by R2 Corp. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 32 days - a notably fast clearance cycle.

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

View all R2 Corp. devices

Submission Details

510(k) Number K800930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date May 23, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
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 19
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K800930.
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979
ECG CLUSTER ELECTRODE
K771776 · C.R. Bard, Inc. · Nov 1977