Cleared Traditional

K983232 - PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT

K983232 is an FDA 510(k) clearance for PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/..., manufactured by Tz Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K983232 · Tz Medical, Inc. · Cardiovascular device
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Sep 1999
Decision
366d
Days
Class 2
Risk

K983232 is an FDA 510(k) clearance for the PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODE.... 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 366 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

FDA 510(k) Submission Details - K983232

510(k) Number K983232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date September 15, 1999
Days to Decision 366 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
241d slower than avg
Panel avg: 125d · This submission: 366d
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 55
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