Cleared Traditional

K910181 - HITT BY HEMOCHRON

K910181 is the FDA 510(k) clearance for HITT BY HEMOCHRON by International Technidyne Corp.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K910181 · International Technidyne Corp. · Hematology device
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May 1991
Decision
114d
Days
Class 2
Risk

K910181 is an FDA 510(k) clearance for the HITT BY HEMOCHRON(R). Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 10, 1991 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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 International Technidyne Corp. devices

Submission Details

510(k) Number K910181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date May 10, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 113d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 23
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K910181.
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994
BERICHROM HEPARIN
K925200 · Behring Diagnostics, Inc. · Jun 1993
HEPARIN CONTROLS, HIGH AND LOW
K910741 · Sigma Diagnostics, Inc. · Apr 1991
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990