Cleared Traditional

THROMBOPLASTIN.C PLUS (K901325) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901325 · Baxter Healthcare Corp · Hematology device
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May 1990
Decision
42d
Days
Class 2
Risk

K901325 is an FDA 510(k) clearance for the THROMBOPLASTIN.C PLUS. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K901325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1990
Decision Date May 02, 1990
Days to Decision 42 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
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 54
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K901325.
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · Helena Laboratories · Apr 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
K905857 · Helena Laboratories · Feb 1991
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989
DADE THROMBOPLASTIN IS
K891169 · Baxter Healthcare Corp · Apr 1989
VISION(R) PROTHROMBIN TIME
K883441 · Abbott Laboratories · Sep 1988