Cleared Traditional

K855015 - NONINVASIVE TEMP. PACEMAKER NTP-1000

K855015 is an FDA 510(k) clearance for NONINVASIVE TEMP. PACEMAKER NTP-1000, 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 105-day FDA review.

K855015 · Zmi Corp. · Cardiovascular device
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Mar 1986
Decision
105d
Days
Class 2
Risk

K855015 is an FDA 510(k) clearance for the NONINVASIVE TEMP. PACEMAKER NTP-1000. 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 March 31, 1986 after a review of 105 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 - K855015

510(k) Number K855015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date March 31, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K855015.
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AMENDMENT LIFEPAK 8, NPN 052
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LIFEPAK 8 MODIFICATION
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