Cleared Traditional

DADE THROMBOPLASTIN IS (K891169) - FDA 510(k) Clearance

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

K891169 · Baxter Healthcare Corp · Hematology device
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Apr 1989
Decision
35d
Days
Class 2
Risk

K891169 is an FDA 510(k) clearance for the DADE THROMBOPLASTIN IS. 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 April 10, 1989 after a review of 35 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 K891169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date April 10, 1989
Days to Decision 35 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
78d faster than avg
Panel avg: 113d · This submission: 35d
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 K891169.
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990
THROMBOPLASTIN.C PLUS
K901325 · Baxter Healthcare Corp · May 1990
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989
VISION(R) PROTHROMBIN TIME
K883441 · Abbott Laboratories · Sep 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · Em Diagnostic Systems, Inc. · Feb 1988
THROMBOPLASTIN.C
K874592 · Baxter Healthcare Corp · Feb 1988