Cleared Traditional

K874090 - 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER

K874090 is an FDA 510(k) clearance for 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER, manufactured by Medac, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K874090 · Medac, Inc. · Cardiovascular device
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Dec 1987
Decision
69d
Days
Class 2
Risk

K874090 is an FDA 510(k) clearance for the 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Medac, Inc. (Tualatin, US). The FDA issued a Cleared decision on December 15, 1987 after a review of 69 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 Medac, Inc. devices

FDA 510(k) Submission Details - K874090

510(k) Number K874090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1987
Decision Date December 15, 1987
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
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 K874090.
MODEL #918 MULTI-PADS
K883375 · Cardiotronics, Inc. · Aug 1988
TRIAD-EP
K880936 · Cardiotronics, Inc. · Jul 1988
QUIK-PACE NONINVASIVE PACEMAKER
K871751 · Physio-Control Corp. · Dec 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368 · Conmedcorp · Sep 1987
LECTEC NON-INVASIVE PACING ELECTRODE
K872012 · Lectec Corp. · Jun 1987
STAT-PAD (TM)
K871538 · Cardiac Resucitator Corp. · Jun 1987