510(k) · Cleared
Recalled · Class III · 2021Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · JPK Mixture, Hematology Quality Control
Cleared on Sep 20, 1995 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 20, 1995
- Review
- 97 days
- Class
- Class II
- Product code
- JPK
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK952720 Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & IIAalto Scientific, Ltd. · 1995
- Descendant · cites it directly · 1 of its ownK041635 G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK081269 Avie A1C Test SystemMec Dynamics Corp · 2009
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) | K952720 | Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II | Aalto Scientific, Ltd. | 1995 | — |
| +1 | K041635 | G5 I HBA1C Test, G5 II HBA1C Test | Provalis Diagnostics, Ltd. | 2004 | 4 |
| +2 | K081269 | Avie A1C Test System | Mec Dynamics Corp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPK? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K041635 | G5 I HBA1C Test, G5 II HBA1C Test | 2004 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2021 | Class III | Z-0350-2023 | Nonconforming Material/Component | The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer… |
| Oct 5, 2021 | Class III | Z-0349-2023 | Nonconforming Material/Component | The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which… |
| Aug 18, 2005 | Not classified | Z-0131-06 | Other | The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041635 (Provalis Diagnostics, Ltd., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 5 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952720: Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952720
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026