510(k) · Cleared
ClearedCareside Ammonia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · JID Photometric Method, Ammonia
Cleared on Aug 3, 1999 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 105-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 3, 1999
- Review
- 105 days
- Class
- Class I
- Product code
- JID
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK991371 Careside AmmoniaCareside, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K991371 | Careside Ammonia | Careside, Inc. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…n’s (formerly Eastman Kodak, Inc.) Vitros NH; Slides for Johnson and Johnson’s Vitros DT 60 II system (formerly Eastman Kodak’s DT 60 II). Predicate Device 510K number: K912844/A Product Code: 75JID AT — CARESIDE, Inc. CARESIDE™ Ammonia Premarket Notification Page 11 April 16, 1999 Iv… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
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 | — |
What is it indicated for?
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure ammonia from anti-coagulated whole blood or plasma specimens to aid in the diagnosis and treatment of patients with severe liver disorders such as cirrhosis, hepatitis, and Reye’s syndrome.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991371 · printed Nov 3, 2026
Cite this page
510(k) Report. “K991371: Careside Ammonia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K991371
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026