Cleared Special

K200909 - Hemo Control (optional Add Pack Hemo Control DM)

K200909 is an FDA 510(k) clearance for Hemo Control (optional Add Pack Hemo Co..., manufactured by Ekf Diagnostic GmbH. The device is a Class 2 Hematology device with product code GKR cleared through the Special 510(k) pathway after a 67-day FDA review.

K200909 · Ekf Diagnostic GmbH · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
67d
Days
Class 2
Risk

K200909 is an FDA 510(k) clearance for the Hemo Control (optional Add Pack Hemo Control DM). Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on June 12, 2020 after a review of 67 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.

FDA 510(k) Submission Details - K200909

510(k) Number K200909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date June 12, 2020
Days to Decision 67 days
Submission Type Special
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
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

GKR Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K200909.
HemoCue Hb 301 System
K201217 · Hemocue AB · Aug 2020
HemoCue Hb 801 System
K181751 · Hemocue AB · Feb 2019
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
hemochroma PLUS System
K163465 · Immunostics Inc., · Sep 2017
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · ACON Laboratories, Inc. · Aug 2013
K200909 · Hemo Control (optional Add Pack Hemo Control DM)
Download PDF FDA Summary Ekf Diagnostic GmbH