Cleared Traditional

ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (K800932) - FDA 510(k) Clearance

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

K800932 · R2 Corp. · Cardiovascular device
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May 1980
Decision
32d
Days
Class 2
Risk

K800932 is an FDA 510(k) clearance for the ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), 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 870.2900 - 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 K800932 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 DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 40
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K800932.
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · Medtronic Vascular · Jan 1989
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · Medtronic Vascular · Mar 1988
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · Intermedics, Inc. · Mar 1982
3M R.F. CURRENT SUPPRESSOR
K801041 · 3M Company · May 1980
RF CHOKE CABLE
K771750 · C.R. Bard, Inc. · Sep 1977