Cleared Traditional

K843459 - HEMOTEC ACT I SYSTEM

K843459 is the FDA 510(k) clearance for HEMOTEC ACT I SYSTEM by Hemotec, Inc.. It is a Class 2 Hematology device (product code JBP) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K843459 · Hemotec, Inc. · Hematology device
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Dec 1984
Decision
98d
Days
Class 2
Risk

K843459 is an FDA 510(k) clearance for the HEMOTEC ACT I SYSTEM. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Hemotec, Inc. (Attleboro, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 Hemotec, Inc. devices

Submission Details

510(k) Number K843459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date December 12, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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.

Regulatory Peers - JBP Activated Whole Blood Clotting Time

All 8
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K843459.
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991
HEMOCHRON THROMBOCHRONOMETER
K832189 · International Technidyne Corp. · Oct 1983