Cleared Traditional

K885166 - ZMI PART NO. NTP-2100

K885166 is the FDA 510(k) clearance for ZMI PART NO. NTP-2100 by Zmi Corp.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K885166 · Zmi Corp. · Cardiovascular device
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May 1989
Decision
139d
Days
Class 2
Risk

K885166 is an FDA 510(k) clearance for the ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Zmi Corp. (Woburn, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 139 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 K885166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1988
Decision Date May 01, 1989
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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 K885166.
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · Physio-Control Corp. · Sep 1991
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · Nihon Kohden America, Inc. · Dec 1989
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