Cleared Traditional

K854687 - ERMA HB-METER MODEL 303N

K854687 is an FDA 510(k) clearance for ERMA HB-METER MODEL 303N, manufactured by Future Impex Corp.. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K854687 · Future Impex Corp. · Hematology device
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Jun 1986
Decision
196d
Days
Class 2
Risk

K854687 is an FDA 510(k) clearance for the ERMA HB-METER MODEL 303N. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on June 4, 1986 after a review of 196 days - an extended review cycle.

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

FDA 510(k) Submission Details - K854687

510(k) Number K854687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date June 04, 1986
Days to Decision 196 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 113d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 31
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K854687.
TOTAL HEMOGLOBIN
K863104 · J. D. Assoc. · Sep 1986
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641 · U. S. Diagnostics, Inc. · Aug 1986
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986
HEMOGLOBIN REAGENT SET
K860475 · Sterling Diagnostics, Inc. · Mar 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 1985
HEMOGLOBIN ANALYZER
K851467 · Awareness Technology, Inc. · Jul 1985