510(k) · Cleared
Recalled · Class II · 2019Kodak Ektachem 250 Analyer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jul 10, 1992 after a 67-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 15 times.
- Decided
- Jul 10, 1992
- Review
- 67 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 15
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK922072 Kodak Ektachem 250 AnalyerEastman Kodak Company · 1992
- Descendant · cites it directly · 1 of its ownK023875 Vitros Chemistry Products Alb Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK191316 VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK091975 Integrated Laboratory Automation SolutionIntegrated Laboratory Automation Solutions, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K023875Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4Ortho-Clinical Diagnostics, Inc. · 2002 · cites it directly1descendant
- K191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 2 generations on0descendants
- K091975Integrated Laboratory Automation SolutionIntegrated Laboratory Automation Solutions, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922072 | Kodak Ektachem 250 Analyer | Eastman Kodak Company | 1992 | — |
| +1 | K023875 | Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4 | Ortho-Clinical Diagnostics, Inc. | 2002 | 1 |
| +2 | K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +1 | K091975 | Integrated Laboratory Automation Solution | Integrated Laboratory Automation Solutions, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Jul 8, 2019 | Class II | Z-2176-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2174-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2175-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2177-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Apr 8, 2019 | Class II | Z-1933-2019 | Device Design | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. |
| Apr 8, 2019 | Class II | Z-1934-2019 | Device Design | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. |
| Apr 8, 2019 | Class II | Z-1936-2019 | Device Design | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. |
| Apr 8, 2019 | Class II | Z-1935-2019 | Device Design | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. |
| Dec 21, 2015 | Class II | Z-1071-2016 | Error in labeling | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition… |
| Dec 21, 2015 | Class II | Z-1072-2016 | Error in labeling | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition… |
| Jan 9, 2014 | Class II | Z-1226-2014 | Error in labeling | An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658. |
| Oct 17, 2013 | Class II | Z-1088-2014 | Under Investigation by firm | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. |
| Jun 12, 2013 | Class II | Z-0296-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Jun 12, 2013 | Class II | Z-0305-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Feb 2, 2012 | Not classified | Z-1277-2012 | Software design | Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data… |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023875 (Ortho-Clinical Diagnostics, Inc., 2002) has gone furthest, with 1 descendant 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/K922072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922072: Kodak Ektachem 250 Analyer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922072
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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