Cleared Traditional

R2 ESU CABLE-ADAPTER MODELS 160,161 (K800934) - FDA 510(k) Clearance

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

K800934 · R2 Corp. · Physical Medicine device
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May 1980
Decision
29d
Days
Class 2
Risk

K800934 is an FDA 510(k) clearance for the R2 ESU CABLE-ADAPTER MODELS 160,161. Classified as Cable, Electrode (product code IKD), Class II - Special Controls.

Submitted by R2 Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1175 - the FDA physical medicine device 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 K800934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date May 20, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKD Cable, Electrode
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1175
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 Physical Medicine devices follow this clearance model.