Cleared Traditional

K895009 - GEL-TAC(R)

K895009 is an FDA 510(k) clearance for GEL-TAC, manufactured by Padeco, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K895009 · Padeco, Inc. · Cardiovascular device
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Dec 1989
Decision
127d
Days
Class 2
Risk

K895009 is an FDA 510(k) clearance for the GEL-TAC(R). Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Padeco, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Padeco, Inc. devices

FDA 510(k) Submission Details - K895009

510(k) Number K895009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date December 13, 1989
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 117
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K895009.
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · Marquette Electronics, Inc. · Jul 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · Physio-Control Corp. · Feb 1990
DEFIB K-PADS
K895662 · Katecho, Inc. · Jan 1990
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · Marquette Electronics, Inc. · Dec 1989
COORDINATOR
K895113 · Cardiotronics, Inc. · Oct 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989