Cleared Traditional

K912714 - RT40 RADIO TRANSLUCENT

K912714 is an FDA 510(k) clearance for RT40 RADIO TRANSLUCENT, manufactured by Bio-Detek, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K912714 · Bio-Detek, Inc. · Cardiovascular device
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Jul 1991
Decision
37d
Days
Class 2
Risk

K912714 is an FDA 510(k) clearance for the RT40 RADIO TRANSLUCENT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Bio-Detek, Inc. (Attleboro, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 37 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.

FDA 510(k) Submission Details - K912714

510(k) Number K912714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date July 25, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

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 252
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K912714.
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K911990 · Somnitec, Inc. · Jun 1991
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K910494 · Medtronic Andover Medical, Inc. · Apr 1991
VER-MED A10017 UNIVERSAL ELECTRODE
K905489 · Vermont Medical, Inc. · Mar 1991
K912714 · RT40 RADIO TRANSLUCENT
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