510(k) · Cleared
Recalled · Class III · 2020Kodatrol I and II Control and Diluent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 9, 1990 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 1990
- Review
- 18 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990
- Descendant · cites it directly · 7 of its ownK041720 Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 4 of its ownK042477 Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK041764 The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004
- Descendant · 3 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly7descendants
- K042477Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on4descendants
- K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004 · cites it directly4descendants
- K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 3 generations on3descendants
- K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | 1990 | — |
| +1 | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2004 | 1 |
| +2 | K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K041764 | The Vitros 5,1 FS Chemistry System | Ortho-Clinical Diagnostics | 2004 | — |
| +3 | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +1 | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 JJY? 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? (16)
See all 163 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 |
|---|---|---|---|---|
| Oct 16, 2020 | Class III | Z-0471-2021 | Under Investigation by firm | Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041720 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K904768 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904768: Kodatrol I and II Control and Diluent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904768
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026