510(k) · Cleared
ClearedHemo Control (optional Add Pack Hemo Control DM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekf-Diagnostic GmbH · GKR System, Hemoglobin, Automated
Cleared on Jun 12, 2020 as substantially equivalent to K031898 (Ekf Diagnostic GmbH, 2003) after a 67-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 12, 2020
- Review
- 67 days
- Class
- Class II
- Product code
- GKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031898 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031898 Ekf Diagnostic Hemo Control Hemoglobin Measurement SystemEkf Diagnostic GmbH · 2003
- This deviceK200909 Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031898 | Ekf Diagnostic Hemo Control Hemoglobin Measurement System | Ekf Diagnostic GmbH | 2003 | — |
| 0 (this device) | K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKR device
- #1 K201217 HemoCue Hb 301 Systemscore 0.4 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031898 | Ekf Diagnostic Hemo Control Hemoglobin Measurement SystemSummary page 5…ortable and cheap check of the device. Predicate Devices: EKF Diagnostic Hemo Control Hemoglobin Measurement System Predicates 510(k): k031898 Special Conditions for Use: For in vitro diagnostic use. Rx Only Special instrument Req… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K031898.
How does its category compare?
All GKR devicesGKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GKR
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKR
Too few GKR 510(k)s in any year since 2007 to give a median.
Recalls per year · GKR
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKR
1in 2024
MAUDE reports naming product code GKR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 2 | — | 1 | 43 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.
For in-vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200909: Hemo Control (optional Add Pack Hemo Control DM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200909
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026