Cleared Traditional

VISION(TM) HEMOGLOBIN (K862202) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862202 · Abbott Laboratories · Hematology device
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Aug 1986
Decision
69d
Days
Class 2
Risk

K862202 is an FDA 510(k) clearance for the VISION(TM) HEMOGLOBIN. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 18, 1986 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K862202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date August 18, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 113d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K862202.
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · Heraeus Kulzer, Inc. · Feb 1989
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
K880038 · Sigma Diagnostics, Inc. · Apr 1988
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · Em Diagnostic Systems, Inc. · Jul 1987
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 1985
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · Miles Laboratories, Inc. · Jul 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · Miles Laboratories, Inc. · Jul 1982