510(k) · Cleared
ClearedHemoCue Hb 301 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocue AB · GKR System, Hemoglobin, Automated
Cleared on Aug 4, 2020 as substantially equivalent to K181751 (Hemocue AB, 2019) after a 90-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Aug 4, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032203 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK032203 Hemocue Hemoglobin 201 + System Article 121704Hemocue, Inc. · 2003 · Recalled
- 2 generations backK061047 Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 2006
- 1 generation backK181751 HemoCue Hb 801 SystemHemocue AB · 2019
- This deviceK201217 HemoCue Hb 301 SystemHemocue AB · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032203 | Hemocue Hemoglobin 201 + System Article 121704 | Hemocue, Inc. | 2003 | 1 |
| −2 | K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 | Hemocue AB | 2006 | — |
| −1 | K181751 | HemoCue Hb 801 System | Hemocue AB | 2019 | — |
| 0 (this device) | K201217 | HemoCue Hb 301 System | Hemocue AB | 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 K200909 Hemo Control (optional Add Pack Hemo Control DM)score -0.5 · 1 generation · 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 |
|---|---|---|---|
| * | K181751 | HemoCue Hb 801 SystemSummary page 7…tem Common name: Hemoglobin analyzing system Hemoglobin analyzing system 510(k) number K061047 K181751 Product code GKR GKR Classification Class II… | 2019 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
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?
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.
The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.
The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201217: HemoCue Hb 301 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201217
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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