Cleared Traditional

K181751 - HemoCue Hb 801 System

K181751 is the FDA 510(k) clearance for HemoCue Hb 801 System by Hemocue AB. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K181751 · Hemocue AB · Hematology device
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Feb 2019
Decision
214d
Days
Class 2
Risk

K181751 is an FDA 510(k) clearance for the HemoCue Hb 801 System. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Hemocue AB (Ängelholm, SE). The FDA issued a Cleared decision on February 1, 2019 after a review of 214 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Hemocue AB devices

Submission Details

510(k) Number K181751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date February 01, 2019
Days to Decision 214 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 113d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 12
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K181751.
HemoCue Hb 301 System
K201217 · Hemocue AB · Aug 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · Ekf Diagnostic GmbH · Jun 2020
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · ACON Laboratories, Inc. · Aug 2013
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995