Cleared Special

K020138 - STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

K020138 is an FDA 510(k) clearance for STAT-SITE MHGB METER, manufactured by Gds Technology. The device is a Class 2 Hematology device with product code KHG cleared through the Special 510(k) pathway after a 26-day FDA review.

K020138 · Gds Technology · Hematology device
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Feb 2002
Decision
26d
Days
Class 2
Risk

K020138 is an FDA 510(k) clearance for the STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST C.... Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Gds Technology (Elkhart, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - 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.

FDA 510(k) Submission Details - K020138

510(k) Number K020138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date February 11, 2002
Days to Decision 26 days
Submission Type Special
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
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

KHG Device Classification - Class 2, Special Controls

Product Code KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 - KHG Whole Blood Hemoglobin Determination

All 38
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K020138.
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K020138 · STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
Download PDF Gds Technology