Cleared Traditional

K983196 - PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983196 · Tz Medical, Inc. · Cardiovascular device
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Sep 1999
Decision
369d
Days
Class 2
Risk

K983196 is an FDA 510(k) clearance for the PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S). Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Tz Medical, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 15, 1999 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tz Medical, Inc. devices

Submission Details

510(k) Number K983196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date September 15, 1999
Days to Decision 369 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 125d · This submission: 369d
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.