510(k) · Cleared
ClearedHemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801
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 Jun 8, 2006 as substantially equivalent to K032203 (Hemocue, Inc., 2003) after a 55-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- Jun 8, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- GKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032203 (2003). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK032203 Hemocue Hemoglobin 201 + System Article 121704Hemocue, Inc. · 2003 · Recalled
- This deviceK061047 Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 2006
- Descendant · cites it directly · 1 of its ownK181751 HemoCue Hb 801 SystemHemocue AB · 2019
- Descendant · 2 generations on · 0 of its ownK201217 HemoCue Hb 301 SystemHemocue AB · 2020
- Descendant · cites it directly · 0 of its ownK182298 hemochroma PLUS SystemImmunostics Inc., · 2018
- Descendant · cites it directly · 0 of its ownK163465 hemochroma PLUS SystemImmunostics Inc., · 2017
Most influential descendants
Showing 4 of 4 · See all- K181751HemoCue Hb 801 SystemHemocue AB · 2019 · cites it directly1descendant
- K201217HemoCue Hb 301 SystemHemocue AB · 2020 · 2 generations on0descendants
- K182298hemochroma PLUS SystemImmunostics Inc., · 2018 · cites it directly0descendants
- K163465hemochroma PLUS SystemImmunostics Inc., · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032203 | Hemocue Hemoglobin 201 + System Article 121704 | Hemocue, Inc. | 2003 | 1 |
| 0 (this device) | K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 | Hemocue AB | 2006 | — |
| +1 | K181751 | HemoCue Hb 801 System | Hemocue AB | 2019 | — |
| +2 | K201217 | HemoCue Hb 301 System | Hemocue AB | 2020 | — |
| +1 | K182298 | hemochroma PLUS System | Immunostics Inc., | 2018 | — |
| +1 | K163465 | hemochroma PLUS System | Immunostics Inc., | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K032203 | Hemocue Hemoglobin 201 + System Article 121704Summary page 1…ng system Equivalent to: HemoCue AB claims substantial equivalence to the current legally marketed HemoCue Hemoglobin 201 system (K032203) Description The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The micr… | 2003 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061047
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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