Cleared Traditional

K880936 - TRIAD-EP

K880936 is an FDA 510(k) clearance for TRIAD-EP, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K880936 · Cardiotronics, Inc. · Cardiovascular device
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Jul 1988
Decision
133d
Days
Class 2
Risk

K880936 is an FDA 510(k) clearance for the TRIAD-EP. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiotronics, Inc. devices

FDA 510(k) Submission Details - K880936

510(k) Number K880936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date July 18, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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 30
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K880936.
QUIK-PACE II ELECTRODES
K883121 · Physio-Control Corp. · Sep 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338 · Cardiotronics, Inc. · Aug 1988
MODEL #918 MULTI-PADS
K883375 · Cardiotronics, Inc. · Aug 1988
QUIK-PACE NONINVASIVE PACEMAKER
K871751 · Physio-Control Corp. · Dec 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368 · Conmedcorp · Sep 1987
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986