Cleared Special

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (K041234) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041234 · Hemocue, Inc. · Hematology device
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Jun 2004
Decision
31d
Days
Class 2
Risk

K041234 is an FDA 510(k) clearance for the HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemocue, Inc. devices

Submission Details

510(k) Number K041234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date June 10, 2004
Days to Decision 31 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 38
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