510(k) · Cleared
Recalled · Class II · 2018Hemocue Hemotrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direct Solutions · GGM Control, Hemoglobin
Cleared on Nov 6, 1996 after a 37-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 6, 1996
- Review
- 37 days
- Class
- Class II
- Product code
- GGM
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK964052 Hemocue HemotrolDirect Solutions · 1996
- Descendant · cites it directly · 1 of its ownK182744 HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V. · 2019
- Descendant · 2 generations on · 0 of its ownK192842 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964052 | Hemocue Hemotrol | Direct Solutions | 1996 | — |
| +1 | K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | 2019 | — |
| +2 | K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 GGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | HemoCue Whole Blood Control Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2018 | Class II | Z-0514-2019 | Material/Component Contamination | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| Oct 18, 2018 | Class II | Z-0515-2019 | Material/Component Contamination | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182744 (Eurotrol B.V., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GGM devicesGGM Control, Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGM
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · GGM
Too few GGM 510(k)s in any year since 2007 to give a median.
Recalls per year · GGM
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGM
1in 2018
MAUDE reports naming product code GGM, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K964052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964052: Hemocue Hemotrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964052
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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