510(k) · Cleared
ClearedElecsys Estradiol 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 24, 1999 as substantially equivalent to K965109 (Boehringer Mannheim Corp., 1997) after a 21-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Sep 24, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965109 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK965109 Elecsys Estradiol AssayBoehringer Mannheim Corp. · 1997
- This deviceK992981 Elecsys Estradiol Calset IIRoche Diagnostics Corp. · 1999
- Descendant · cites it directly · 1 of its ownK142021 Elecsys Estradiol III CalSetRoche Diagnostics · 2014
- Descendant · 2 generations on · 0 of its ownK163053 Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc. · 2016
- Descendant · cites it directly · 0 of its ownK101460 Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965109 | Elecsys Estradiol Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K992981 | Elecsys Estradiol Calset II | Roche Diagnostics Corp. | 1999 | — |
| +1 | K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | 2014 | — |
| +2 | K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016 | — |
| +1 | K101460 | Loci 8 Calibrator, Model KC 646 | Siemens Healthcare Diagnostics | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K965109 | Elecsys Estradiol AssaySummary page 1…to other devices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Elecsys® Estradiol CalSet cleared under document K965109. 25 EGULATORY AFFAIRS 3178452324 09/20 '99 11:43 NO.688 04/10 510(k) Summary — Elecsys® Estradiol CalSet Il,… | 1997 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K142021 (Roche Diagnostics, 2014) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.
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/K992981 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992981: Elecsys Estradiol Calset II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992981
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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