Cleared Traditional

K885166 - ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES

K885166 is an FDA 510(k) clearance for ZMI PART NO. NTP-2100, manufactured by Zmi Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K885166

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.

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 K885166.
MODEL 205 SHOCK-TRODE
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NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · Nihon Kohden America, Inc. · Dec 1989
DEFIB/PACING PADS
K894588 · Conmedcorp · Oct 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
K885171 · Andover Medical, Inc. · Jan 1989
MRL PACETTE, 450SLL
K880932 · Medical Research Laboratories, Inc. · Dec 1988
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532 · Cardiotronics, Inc. · Nov 1988