Cleared Traditional

K893533 - FACTOR V DEFICIENT PLASMA

K893533 is the FDA 510(k) clearance for FACTOR V DEFICIENT PLASMA by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K893533 · Medical Diagnostic Technologies, Inc. · Hematology device
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Jun 1989
Decision
46d
Days
Class 2
Risk

K893533 is an FDA 510(k) clearance for the FACTOR V DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K893533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date June 23, 1989
Days to Decision 46 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
67d faster than avg
Panel avg: 113d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 62
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K893533.
FACTOR X DEFICIENT PLASMA
K893523 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR IX DEFICIENT PLASMA
K893524 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR VIII DEFICIENT PLASMA
K893525 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR XII DEFICIENT PLASMA
K893534 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR VII DEFICIENT PLASMA
K893535 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR XI DEFICIENT PLASMA
K893536 · Medical Diagnostic Technologies, Inc. · Jun 1989