510(k) · Cleared
ClearedElecsys Folate II Calset II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIT Calibrator, Secondary
Cleared on Sep 30, 2004 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 30, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK042490 Elecsys Folate II Calset IIRoche Diagnostics Corp. · 2004
- Descendant · cites it directly · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- Descendant · 2 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 2 generations on · 1 of its ownK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011
- Descendant · 4 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · cites it directly7descendants
- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 2 generations on3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 3 generations on2descendants
- K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011 · 2 generations on1descendant
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042490 | Elecsys Folate II Calset II | Roche Diagnostics Corp. | 2004 | — |
| +1 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| +2 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +3 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +2 | K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset | Roche Diagnostics | 2011 | — |
| +4 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 JIT? 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys… | 2009 | 7 |
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?
- Of its descendants, K082340 (Roche Diagnostics Corp., 2009) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K042490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042490: Elecsys Folate II Calset II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042490
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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