510(k) · Cleared
Recalled · Class II · 2023Kodak Ektacchem 950IRC Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Diagnostic Systems, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jan 17, 1995 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 1995
- Review
- 35 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK946090 Kodak Ektacchem 950IRC AnalyzerClinical Diagnostic Systems, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK073223 S-Test C02Alfa Wassermann Diagnostic Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK072356 S-Test CAAlfa Wassermann Diagnostic Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK031924 Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL…Ortho-Clinical Diagnostics · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K073223S-Test C02Alfa Wassermann Diagnostic Technologies, Inc. · 2008 · cites it directly0descendants
- K072356S-Test CAAlfa Wassermann Diagnostic Technologies, Inc. · 2008 · cites it directly0descendants
- K031924Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…Ortho-Clinical Diagnostics · 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) | K946090 | Kodak Ektacchem 950IRC Analyzer | Clinical Diagnostic Systems, Inc. | 1995 | — |
| +1 | K073223 | S-Test C02 | Alfa Wassermann Diagnostic Technologies, Inc. | 2008 | — |
| +1 | K072356 | S-Test CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008 | — |
| +1 | K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack… | Ortho-Clinical Diagnostics | 2003 | 29 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 2 | 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 JJE? 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)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2023 | Class II | Z-2624-2023 | Under Investigation by firm | Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073223 (Alfa Wassermann Diagnostic Technologies, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
https://510kreport.com/device/K946090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946090: Kodak Ektacchem 950IRC Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946090
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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