Cleared Traditional

K940801 - K-KLIP

K940801 is an FDA 510(k) clearance for K-KLIP, manufactured by Katecho, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K940801 · Katecho, Inc. · Cardiovascular device
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Aug 1994
Decision
162d
Days
Class 2
Risk

K940801 is an FDA 510(k) clearance for the K-KLIP. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 - K940801

510(k) Number K940801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date August 03, 1994
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 181
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K940801.
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