Cleared Traditional

K911745 - SIMPLATE PEDIATRIC

K911745 is an FDA 510(k) clearance for SIMPLATE PEDIATRIC, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code JCA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K911745 · Organon Teknika Corp. · Hematology device
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Aug 1991
Decision
113d
Days
Class 2
Risk

K911745 is an FDA 510(k) clearance for the SIMPLATE PEDIATRIC. Classified as Device, Bleeding Time (product code JCA), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 9, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6100 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K911745

510(k) Number K911745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1991
Decision Date August 09, 1991
Days to Decision 113 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
At panel average
Panel avg: 113d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCA Device Classification - Class 2, Special Controls

Product Code JCA Device, Bleeding Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6100
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 - JCA Device, Bleeding Time

Devices cleared under the same product code (JCA) and FDA review panel - the closest regulatory comparables to K911745.
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · International Technidyne Corp. · Jul 1991
Q.I.C. BLEEDING TIME DEVICE
K871318 · Helena Laboratories · Jun 1987
SURGICUTT - BLEEDING TIME DEVICE
K850542 · International Technidyne Corp. · Mar 1985
BLEEDING TIME DEVICE DISPOSABLE
K830645 · American Dade · Mar 1983
SIMPLATE
K761250 · General Diagnostics · Mar 1977