510(k) · Cleared
ClearedImmulite 2000 Free T4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Feb 2, 2009 as substantially equivalent to K961510 (Ciba Corning Diagnostics Corp., 1996) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Feb 2, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902336 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 1 generation backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- This deviceK083373 Immulite 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK160647 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −1 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| 0 (this device) | K083373 | Immulite 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2009 | — |
| +1 | K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K961510 | Acs FRT4 ImmunoassaySummary page 2…(k971792). The revised IMMULITE 2000 Free T4 assay, described in this submission, is predicated on the Siemens Healthcare Diagnostics ADVIA Centaur Free T4 (FrT4) assay (k961510/k971418). A summary of the features of the IMMULITE 2000 Free T4 assay and the predicate device ADVIA Centaur FrT4 is presented b… | 1996 |
| * | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerSummary page 2…). The revised IMMULITE 2000 Free T4 assay, described in this submission, is predicated on the Siemens Healthcare Diagnostics ADVIA Centaur Free T4 (FrT4) assay (k961510/k971418). A summary of the features of the IMMULITE 2000 Free T4 assay and the predicate device ADVIA Centaur FrT4 is presented below.… | 1997 |
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 |
|---|---|---|---|
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | 2016 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K160647 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K961510.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The IMMULITE® 2000 Free Thyroxine Assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of non-protein-bound thyroxine (free T4) in serum and heparinized plasma, as an aid in the clinical assessment of thyroid status.
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/K083373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083373: Immulite 2000 Free T4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083373
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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