Cleared Traditional

K991439 - POLLER CALIBRANTS

K991439 is an FDA 510(k) clearance for POLLER CALIBRANTS, manufactured by European Concerted Action on Anticoagulation. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K991439 · European Concerted Action on Anticoagulation · Hematology device
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Dec 1999
Decision
238d
Days
Class 2
Risk

K991439 is an FDA 510(k) clearance for the POLLER CALIBRANTS. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by European Concerted Action on Anticoagulation (Manchester, GB). The FDA issued a Cleared decision on December 20, 1999 after a review of 238 days - an extended review cycle.

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 European Concerted Action on Anticoagulation devices

FDA 510(k) Submission Details - K991439

510(k) Number K991439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date December 20, 1999
Days to Decision 238 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
125d slower than avg
Panel avg: 113d · This submission: 238d
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 K991439.
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · Diagnostica Stago, Inc. · Apr 2001
THROMBOSTRATE CONTROL PLASMAS
K000679 · Pacific Hemostasis · Mar 2000
HMP CONTROLS (TAS) RAPIDPOINT
K994159 · Cardiovascular Diagnostics, Inc. · Feb 2000
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · Pacific Hemostasis · Aug 1999
HEPARIN CONTROL PLASMA LEVEL 2
K992279 · Pacific Hemostasis · Aug 1999