Cleared Traditional

K914949 - COAGULATION ARPR,CAT.NO.5185

K914949 is an FDA 510(k) clearance for COAGULATION ARPR, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K914949 · Helena Laboratories · Hematology device
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Mar 1992
Decision
121d
Days
Class 2
Risk

K914949 is an FDA 510(k) clearance for the COAGULATION ARPR,CAT.NO.5185. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K914949

510(k) Number K914949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date March 04, 1992
Days to Decision 121 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
8d slower than avg
Panel avg: 113d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K914949.
CLIBRATION PLASMAS
K924404 · Behring Diagnostics, Inc. · Dec 1992
COAG-CONTROL [N] KIT
K922174 · American Bioproducts Co. · Oct 1992
THROMBO-CALIBRATOR KIT
K921344 · American Bioproducts Co. · Jun 1992
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · Helena Laboratories · Aug 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
K905673 · Helena Laboratories · Feb 1991
COAGULATION CONTROL, LEVEL I
K902361 · Sigma Chemical Co. · Jul 1990