Cleared Traditional

K940426 - MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER

K940426 is an FDA 510(k) clearance for MEDTRONIC HEMOTEC ACT II AUTOMATED COAG..., manufactured by Medtronic Hemotec, Inc.. The device is a Class 2 Hematology device with product code GKN cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K940426 · Medtronic Hemotec, Inc. · Hematology device
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Sep 1994
Decision
232d
Days
Class 2
Risk

K940426 is an FDA 510(k) clearance for the MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER. Classified as Timer, Clot, Automated (product code GKN), Class II - Special Controls.

Submitted by Medtronic Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 232 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Hemotec, Inc. devices

FDA 510(k) Submission Details - K940426

510(k) Number K940426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1994
Decision Date September 20, 1994
Days to Decision 232 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 113d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKN Device Classification - Class 2, Special Controls

Product Code GKN Timer, Clot, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.