Cleared Traditional

K915746 - SIMPLASTIN L

K915746 is an FDA 510(k) clearance for SIMPLASTIN L, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K915746 · Organon Teknika Corp. · Hematology device
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Feb 1992
Decision
51d
Days
Class 2
Risk

K915746 is an FDA 510(k) clearance for the SIMPLASTIN L. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on February 12, 1992 after a review of 51 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K915746

510(k) Number K915746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date February 12, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

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 102
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K915746.
NEOPLASTINE(R) CI KIT
K922565 · American Bioproducts Co. · Dec 1992
DADE RECOMBOPLASTIN S
K921326 · Baxter Diagnostics, Inc. · Jul 1992
NEOPLASTINE CI PLUS
K922040 · American Bioproducts Co. · Jun 1992
ACS ULTRA-1 THROMBOPLASTIN
K913249 · Analytical Control Systems, Inc. · Dec 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · Analytical Control Systems, Inc. · Nov 1991
ACS LIQUID THROMBOPLASTIN
K912102 · Analytical Control Systems, Inc. · Aug 1991