510(k) · Cleared
Recalled · Class II · 2013Hemocue Hemoglobin 201 + System Article 121704
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocue, Inc. · GKR System, Hemoglobin, Automated
Cleared on Aug 25, 2003 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 2003
- Review
- 38 days
- Class
- Class II
- Product code
- GKR
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK032203 Hemocue Hemoglobin 201 + System Article 121704Hemocue, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK061047 Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 2006
- Descendant · 2 generations on · 1 of its ownK181751 HemoCue Hb 801 SystemHemocue AB · 2019
- Descendant · cites it directly · 0 of its ownK221508 AnemoCheck HomeSanguina, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK201217 HemoCue Hb 301 SystemHemocue AB · 2020
- Descendant · 2 generations on · 0 of its ownK182298 hemochroma PLUS SystemImmunostics Inc., · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K061047Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 2006 · cites it directly4descendants
- K181751HemoCue Hb 801 SystemHemocue AB · 2019 · 2 generations on1descendant
- K221508AnemoCheck HomeSanguina, Inc. · 2023 · cites it directly0descendants
- K201217HemoCue Hb 301 SystemHemocue AB · 2020 · 3 generations on0descendants
- K182298hemochroma PLUS SystemImmunostics Inc., · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032203 | Hemocue Hemoglobin 201 + System Article 121704 | Hemocue, Inc. | 2003 | — |
| +1 | K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 | Hemocue AB | 2006 | — |
| +2 | K181751 | HemoCue Hb 801 System | Hemocue AB | 2019 | — |
| +1 | K221508 | AnemoCheck Home | Sanguina, Inc. | 2023 | — |
| +3 | K201217 | HemoCue Hb 301 System | Hemocue AB | 2020 | — |
| +2 | K182298 | hemochroma PLUS System | Immunostics Inc., | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2013 | Class II | Z-0101-2014 | Packaging | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061047 (Hemocue AB, 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GKR devicesGKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCueB Hb 201 Microcuvettes are intended for use in the HemoCueB Hb 20 1' analyzer. The HemoCue 20 1 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 20 1' analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201' analyzer is only to be used…
Read the full statement (150 words)
Quantitative determination of hemoglobin in capillary, venous and arterial whole blood.
The HemoCueB Hb 201 Microcuvettes are intended for use in the HemoCueB Hb 20 1' analyzer. The HemoCue 20 1 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 20 1' analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201' analyzer is only to be used with HemoCue Hb 201 Microcuvettes.
The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 20 1' analyzer is only to be used together with HemoCue Hb 20 1 microcuvettes. The use of any other device in the HemoCue Hb 201' analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences.
The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032203: Hemocue Hemoglobin 201 + System Article 121704.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032203
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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