510(k) · Cleared
ClearedImx Estradiol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JIS Calibrator, Primary
Cleared on May 17, 1995 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 17, 1995
- Review
- 61 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK951629 Imx EstradiolAbbott Laboratories · 1995
- Descendant · cites it directly · 2 of its ownK032458 Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol…Abbott Laboratories · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK111023 Abbott Architect LH CalibratorsAbbott Laboratories · 2011
- Descendant · 3 generations on · 0 of its ownK163521 Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K032458Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx…Abbott Laboratories · 2003 · cites it directly2descendants
- K111023Abbott Architect LH CalibratorsAbbott Laboratories · 2011 · 2 generations on1descendant
- K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951629 | Imx Estradiol | Abbott Laboratories | 1995 | — |
| +1 | K032458 | Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator… | Abbott Laboratories | 2003 | 2 |
| +2 | K111023 | Abbott Architect LH Calibrators | Abbott Laboratories | 2011 | — |
| +3 | K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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 JIS? 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032458 | Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx… | 2003 | 2 |
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, K032458 (Abbott Laboratories, 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K951629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951629: Imx Estradiol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951629
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026