Cleared Traditional

K895728 - R2 PACE ADAPTOR CABLE, MODEL 196

K895728 is an FDA 510(k) clearance for R2 PACE ADAPTOR CABLE, manufactured by Darox Corp.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K895728 · Darox Corp. · Cardiovascular device
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Oct 1989
Decision
17d
Days
Class 2
Risk

K895728 is an FDA 510(k) clearance for the R2 PACE ADAPTOR CABLE, MODEL 196. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Darox Corp. (Niles, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Darox Corp. devices

FDA 510(k) Submission Details - K895728

510(k) Number K895728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date October 12, 1989
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 57
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K895728.
MODEL 205 SHOCK-TRODE
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DEFIB/PACING PADS
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K880932 · Medical Research Laboratories, Inc. · Dec 1988
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
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