Cleared Traditional

K041882 - FLOWCARE SYSTEM

K041882 is the FDA 510(k) clearance for FLOWCARE SYSTEM by Pointcare Technologies, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K041882 · Pointcare Technologies, Inc. · Hematology device
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Nov 2004
Decision
134d
Days
Class 2
Risk

K041882 is an FDA 510(k) clearance for the FLOWCARE SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Pointcare Technologies, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Pointcare Technologies, Inc. devices

Submission Details

510(k) Number K041882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date November 23, 2004
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K041882.
CELL-DYN SAPPHIRE SYSTEM
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K043215 · Beckman Coulter, Inc. · Jan 2005
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
K042724 · Beckman Coulter, Inc. · Oct 2004
COULTER A T 5DIFF CAP PIERCE (CP)
K042173 · Beckman Coulter, Inc. · Oct 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · Bayer Healthcare, LLC · Sep 2004