Cleared Traditional

K915328 - GEL-TAC

K915328 is an FDA 510(k) clearance for GEL-TAC, manufactured by Katecho, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K915328 · Katecho, Inc. · Cardiovascular device
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Jun 1992
Decision
216d
Days
Class 2
Risk

K915328 is an FDA 510(k) clearance for the GEL-TAC. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on June 29, 1992 after a review of 216 days - an extended review cycle.

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 Katecho, Inc. devices

FDA 510(k) Submission Details - K915328

510(k) Number K915328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date June 29, 1992
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 125d · This submission: 216d
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 56
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K915328.
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · Hewlett-Packard Co. · May 1995
K-DEFIB/PACE CARBON ELECTRODE
K926175 · Katecho, Inc. · Apr 1993
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757 · Hewlett-Packard Co. · Jul 1992
K-DEFIB/PACE ELECTRODE
K914955 · Katecho, Inc. · May 1992
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · Physio-Control Corp. · Sep 1991
MODEL 205 SHOCK-TRODE
K910661 · Cardiotronics, Inc. · May 1991