510(k) · Cleared
ClearedAalto Scientific Mirco Hematocrit Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · GLK Control, Hematocrit
Cleared on May 14, 2002 as substantially equivalent to K964452 (Richmond Diagnostics, Inc., 1997) after a 78-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 14, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- GLK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964452 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964452 HematachekRichmond Diagnostics, Inc. · 1997
- This deviceK020618 Aalto Scientific Mirco Hematocrit ControlAalto Scientific, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964452 | Hematachek | Richmond Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K020618 | Aalto Scientific Mirco Hematocrit Control | Aalto Scientific, Ltd. | 2002 | — |
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 GLK? 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 |
|---|---|---|---|
| * | K964452 | HematachekSummary page 1….8625, Control, Hematocrit Device to Which Substantial Equivalence is Claimed: STI Hematachek Separation Technology, Inc. 1096 Rainier Drive Altamonte Springs, FLA K964452 Statement of Intended Use: The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate h… | 1997 |
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.
How does its category compare?
All GLK devicesGLK Control, Hematocrit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GLK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GLK
Too few GLK 510(k)s in any year since 2007 to give a median.
Recalls per year · GLK
No recall names GLK since 2007.
Adverse event reports per year · GLK
1in 2020
MAUDE reports naming product code GLK, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aalto Scientific Micro Hematocrit Controls are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020618: Aalto Scientific Mirco Hematocrit Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020618
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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