Cleared Special

Hemo Control (optional Add Pack Hemo Control DM) (K200909) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200909 · Ekf Diagnostic GmbH · Hematology device
Download Printable Device Report (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.

View all Ekf Diagnostic GmbH devices

Submission Details

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.

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.