Cleared Traditional

K895662 - DEFIB K-PADS

K895662 is an FDA 510(k) clearance for DEFIB K-PADS, manufactured by Katecho, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K895662 · Katecho, Inc. · Cardiovascular device
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Jan 1990
Decision
120d
Days
Class 2
Risk

K895662 is an FDA 510(k) clearance for the DEFIB K-PADS. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on January 18, 1990 after a review of 120 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.

FDA 510(k) Submission Details - K895662

510(k) Number K895662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date January 18, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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 165
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K895662.
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · Physio-Control Corp. · Feb 1990
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
K895533 · Matrix Medica, Inc. · Jan 1990
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K900169 · Laerdal Mfg. Corp. · Jan 1990
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.
K894356 · Phycon · Dec 1989
GEL-TAC(R)
K895009 · Padeco, Inc. · Dec 1989
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
K894355 · Phycon · Dec 1989
K895662 · DEFIB K-PADS
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