510(k) · Cleared
ClearedImmulite Total Testosterone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Cleared on Feb 6, 1996 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Feb 6, 1996
- Review
- 40 days
- Class
- Class I
- Product code
- CDZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK955870 Immulite Total TestosteroneDiagnostic Products Corp. · 1996
- Descendant · cites it directly · 0 of its ownK032881 Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total…Diagnostic Products Corp. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955870 | Immulite Total Testosterone | Diagnostic Products Corp. | 1996 | — |
| +1 | K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone | Diagnostic Products Corp. | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 CDZ? 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 CDZ device
- #1 K252728 IDS-iSYS Total Testosteronescore 11.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone | 2003 | 0 |
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, K032881 (Diagnostic Products Corp., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CDZ devicesCDZ Radioimmunoassay, Testosterones And Dihydrotestosterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDZ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDZ
141in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDZ
17in 2025
MAUDE reports naming product code CDZ, 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 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 19 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 7 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 4 | 276 | 0 | 5 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 1 | — | 1 | 5 |
| 2019 | 4 | 141 | 0 | 3 |
| 2020 | 1 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 1 | — | 1 | 3 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 2 | — | 1 | 11 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K955870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955870: Immulite Total Testosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955870
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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