510(k) · Cleared
ClearedEnzymun Test (R) FT4 (Free Thyroxine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CEC Radioimmunoassay, Free Thyroxine
Cleared on May 15, 1990 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 15, 1990
- Review
- 78 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK900883 Enzymun Test (R) FT4 (Free Thyroxine)Boehringer Mannheim Corp. · 1990
- Descendant · cites it directly · 5 of its ownK961489 Elecsys FT4 AssayBoehringer Mannheim Corp. · 1996
- Descendant · 2 generations on · 2 of its ownK131244 Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014
- Descendant · 3 generations on · 0 of its ownK220456 Elecsys FT4 IVRoche Diagnostics · 2023
- Descendant · 3 generations on · 0 of its ownK181233 Elecsys FT4 IIIRoche Diagnostics · 2018
- Descendant · 2 generations on · 0 of its ownK132058 Vidas FT4Biomerieux S.A. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961489Elecsys FT4 AssayBoehringer Mannheim Corp. · 1996 · cites it directly5descendants
- K131244Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014 · 2 generations on2descendants
- K220456Elecsys FT4 IVRoche Diagnostics · 2023 · 3 generations on0descendants
- K181233Elecsys FT4 IIIRoche Diagnostics · 2018 · 3 generations on0descendants
- K132058Vidas FT4Biomerieux S.A. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900883 | Enzymun Test (R) FT4 (Free Thyroxine) | Boehringer Mannheim Corp. | 1990 | — |
| +1 | K961489 | Elecsys FT4 Assay | Boehringer Mannheim Corp. | 1996 | — |
| +2 | K131244 | Elecsys FT4 II Assay, Elecsys FT4 II Calset | Roche Diagnostics | 2014 | — |
| +3 | K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023 | — |
| +3 | K181233 | Elecsys FT4 III | Roche Diagnostics | 2018 | — |
| +2 | K132058 | Vidas FT4 | Biomerieux S.A. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 CEC? 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 CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961489 | Elecsys FT4 Assay | 1996 | 5 |
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, K961489 (Boehringer Mannheim Corp., 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900883: Enzymun Test (R) FT4 (Free Thyroxine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900883
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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