510(k) · Cleared
Recalled · 2004TDX Cortisol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JFT Fluorometric, Cortisol
Cleared on Nov 25, 1985 after a 21-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 once.
- Decided
- Nov 25, 1985
- Review
- 21 days
- Class
- Class II
- Product code
- JFT
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK854419 TDX CortisolAbbott Laboratories · 1985
- Descendant · cites it directly · 1 of its ownK983990 Vitros Immunodiagnostic Products Cortisol AssayOrtho-Clinical Diagnostics, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK060480 Vitros Immunodiagnostic Products Cortisol Reagent Pack and…Ortho-Clinical Diagnostics · 2006
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) | K854419 | TDX Cortisol | Abbott Laboratories | 1985 | — |
| +1 | K983990 | Vitros Immunodiagnostic Products Cortisol Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | — |
| +2 | K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and… | Ortho-Clinical Diagnostics | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 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 JFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFT device
- #1 K242505 Elecsys Cortisol IIIscore 10.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| K983990 | Vitros Immunodiagnostic Products Cortisol Assay | 1998 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2004 | Not classified | Z-0723-04 | Other | The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983990 (Ortho-Clinical Diagnostics, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JFT devicesJFT Fluorometric, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFT
Too few JFT 510(k)s in any year since 2007 to give a median.
Recalls per year · JFT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFT
9in 2025
MAUDE reports naming product code JFT, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 16 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854419: TDX Cortisol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854419
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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