Cleared Special

STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K081719) - FDA 510(k) Clearance

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

K081719 · Stanbio Laboratory · Hematology device
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Jul 2008
Decision
30d
Days
Class 2
Risk

K081719 is an FDA 510(k) clearance for the STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on July 18, 2008 after a review of 30 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 Stanbio Laboratory devices

Submission Details

510(k) Number K081719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date July 18, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
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
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K081719.
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IL682, CO-OXIMETER
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