Cleared Traditional

K933441 - STAGO FACTOR X-DEFICIENT PLASMA

K933441 is the FDA 510(k) clearance for STAGO FACTOR X-DEFICIENT PLASMA by American Bioproducts Co.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K933441 · American Bioproducts Co. · Hematology device
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Oct 1993
Decision
105d
Days
Class 2
Risk

K933441 is an FDA 510(k) clearance for the STAGO FACTOR X-DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on October 27, 1993 after a review of 105 days - within the typical 510(k) review window.

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: 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 American Bioproducts Co. devices

Submission Details

510(k) Number K933441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1993
Decision Date October 27, 1993
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
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 60
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K933441.
STAGO FACTOR IX-DEFICIENT PLASMA
K933432 · American Bioproducts Co. · Nov 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438 · American Bioproducts Co. · Oct 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440 · American Bioproducts Co. · Oct 1993
STAGO FACTOR XI-DEFICIENT PLASMA
K933444 · American Bioproducts Co. · Oct 1993
BIOMERIEUX HEMOLAB COFAC VIII
K933010 · Biomerieux Vitek, Inc. · Sep 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
K924400 · Behring Diagnostics, Inc. · Jun 1993