Cleared Traditional

K873402 - ZOLL NTP-1200 PACER/DEFIBRILLATOR

K873402 is the FDA 510(k) clearance for ZOLL NTP-1200 PACER/DEFIBRILLATOR by Zmi Corp.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K873402 · Zmi Corp. · Cardiovascular device
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Nov 1987
Decision
91d
Days
Class 2
Risk

K873402 is an FDA 510(k) clearance for the ZOLL NTP-1200 PACER/DEFIBRILLATOR. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Zmi Corp. (Cambridge, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 91 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 Zmi Corp. devices

Submission Details

510(k) Number K873402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date November 23, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K873402.
DEFIB/PACING PADS
K894588 · Conmedcorp · Oct 1989
QUIK-PACE II ELECTRODES
K883121 · Physio-Control Corp. · Sep 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
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · Medtronic Vascular · Jul 1986