Cleared Traditional

K884530 - TRIAD-EP II

K884530 is an FDA 510(k) clearance for TRIAD-EP II, 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 20-day FDA review.

K884530 · Cardiotronics, Inc. · Cardiovascular device
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Nov 1988
Decision
20d
Days
Class 2
Risk

K884530 is an FDA 510(k) clearance for the TRIAD-EP II, PLATE INPUT. 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 November 17, 1988 after a review of 20 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 Cardiotronics, Inc. devices

FDA 510(k) Submission Details - K884530

510(k) Number K884530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date November 17, 1988
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
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 K884530.
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · Nihon Kohden America, Inc. · Dec 1989
DEFIB/PACING PADS
K894588 · Conmedcorp · Oct 1989
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532 · Cardiotronics, Inc. · Nov 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
K883178 · Cardiotronics, Inc. · Nov 1988
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
K883304 · Cardiotronics, Inc. · Nov 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523 · Cardiotronics, Inc. · Oct 1988