Cleared Traditional

K843459 - HEMOTEC ACT I SYSTEM

K843459 is an FDA 510(k) clearance for HEMOTEC ACT I SYSTEM, manufactured by Hemotec, Inc.. The device is a Class 2 Hematology device with 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.

FDA 510(k) Submission Details - K843459

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
Combination Product No
PCCP Authorized No
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.

JBP Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K843459.
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
K902081 · Hemotec, Inc. · Jul 1990
TE-25 COAGURO METER
K854686 · Future Impex Corp. · Jun 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · Medical Device Consultants, Inc. · Apr 1986
HEMOCHRON THROMBOCHRONOMETER
K832189 · International Technidyne Corp. · Oct 1983
ACTIVATOR
K790346 · Tri-Med, Inc. · Mar 1979
K843459 · HEMOTEC ACT I SYSTEM
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