Cleared Traditional

K933441 - STAGO FACTOR X-DEFICIENT PLASMA

K933441 is an FDA 510(k) clearance for STAGO FACTOR X-DEFICIENT PLASMA, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K933441

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.

GJT Device Classification - Class 2, Special Controls

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 74
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