Cleared Traditional

K142132 - POOL NORM

K142132 is an FDA 510(k) clearance for POOL NORM, manufactured by Diagnostics Stago S.A.S.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K142132 · Diagnostics Stago S.A.S. · Hematology device
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Dec 2014
Decision
130d
Days
Class 2
Risk

K142132 is an FDA 510(k) clearance for the POOL NORM. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Diagnostics Stago S.A.S. (Gennevilliers, FR). The FDA issued a Cleared decision on December 12, 2014 after a review of 130 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 Diagnostics Stago S.A.S. devices

FDA 510(k) Submission Details - K142132

510(k) Number K142132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date December 12, 2014
Days to Decision 130 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 113d · This submission: 130d
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
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