Cleared Traditional

K081641 - COULTER LIN-X LINEARITY CONTROL

K081641 is an FDA 510(k) clearance for COULTER LIN-X LINEARITY CONTROL, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K081641 · Beckman Coulter, Inc. · Hematology device
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Jan 2009
Decision
219d
Days
Class 2
Risk

K081641 is an FDA 510(k) clearance for the COULTER LIN-X LINEARITY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 219 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K081641

510(k) Number K081641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date January 16, 2009
Days to Decision 219 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
106d slower than avg
Panel avg: 113d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K081641.
UA-CELLULAR FOR IQ
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HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
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CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · R&D Systems, Inc. · Nov 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
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