510(k) · Cleared
Recalled · Class II · 2014Ektachem Clinical Chem. Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · CIG Diazo Colorimetry, Bilirubin
Cleared on Apr 18, 1984 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 18, 1984
- Review
- 51 days
- Class
- Class II
- Product code
- CIG
- Recalls
- 2
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK840880 Ektachem Clinical Chem. SlidesEastman Kodak Company · 1984
- Descendant · cites it directly · 16 of its ownK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · 3 generations on · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 4 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 5 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K991417Abl 735 AnalyzerRadiometer America, Inc. · 1999 · cites it directly16descendants
- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · 2 generations on12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · 3 generations on11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 4 generations on10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840880 | Ektachem Clinical Chem. Slides | Eastman Kodak Company | 1984 | — |
| +1 | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | 2 |
| +2 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| +3 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +4 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +5 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 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? (19)
See all 193 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 |
|---|---|---|---|---|
| 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. |
| Jun 12, 2013 | Class II | Z-0324-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991417 (Radiometer America, Inc., 1999) has gone furthest, with 16 descendants of its own.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K840880 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840880: Ektachem Clinical Chem. Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840880
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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