Cleared Traditional

K912587 - K-FREE

K912587 is the FDA 510(k) clearance for K-FREE by Katecho, Inc.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K912587 · Katecho, Inc. · Cardiovascular device
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Jul 1991
Decision
48d
Days
Class 2
Risk

K912587 is an FDA 510(k) clearance for the K-FREE. 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 July 30, 1991 after a review of 48 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Katecho, Inc. devices

Submission Details

510(k) Number K912587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date July 30, 1991
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K912587.
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · Physio-Control Corp. · Feb 1992
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · Nihon Kohden America, Inc. · Dec 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662 · Marquette Electronics, Inc. · Oct 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · Physio-Control Corp. · Jul 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
DEFIBRILLATOR LEAD ADAPTER
K905065 · Spacelabs, Inc. · Apr 1991