510(k) · Cleared
Recalled · Class II · 2013Kodak Ektachem Clinical Chem. NH3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · JID Photometric Method, Ammonia
Cleared on Apr 1, 1982 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 1, 1982
- Review
- 16 days
- Class
- Class I
- Product code
- JID
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK820723 Kodak Ektachem Clinical Chem. NH3Eastman Kodak Company · 1982
- Descendant · cites it directly · 0 of its ownK260613 AMI™ Plasma Cartridge, AMI™Sequitur Health Corp. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260613AMI™ Plasma Cartridge, AMI™Sequitur Health Corp. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820723 | Kodak Ektachem Clinical Chem. NH3 | Eastman Kodak Company | 1982 | — |
| +1 | K260613 | AMI™ Plasma Cartridge, AMI™ | Sequitur Health Corp. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JID? 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 JID device
- #1 K260613 AMI™ Plasma Cartridge, AMI™score 11.9 · 1 generation · no Class I recall
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260613 | AMI™ Plasma Cartridge, AMI™ | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0297-2014 | 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, K260613 (Sequitur Health Corp., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JID devicesJID Photometric Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JID
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · JID
Too few JID 510(k)s in any year since 2007 to give a median.
Recalls per year · JID
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JID
6in 2025
MAUDE reports naming product code JID, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 1 | 18 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K820723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820723: Kodak Ektachem Clinical Chem. NH3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820723
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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