510(k) · Cleared
ClearedCareside CO2, Total
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on Sep 15, 1999 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Sep 15, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903144 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK903144 Kodak Ektachem Clinical Chemistry Slides (ECO2)Eastman Kodak Company · 1990
- This deviceK992475 Careside CO2, TotalCareside, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903144 | Kodak Ektachem Clinical Chemistry Slides (ECO2) | Eastman Kodak Company | 1990 | — |
| 0 (this device) | K992475 | Careside CO2, Total | Careside, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
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 KHS? 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? (2)
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…s (formerly Eastman Kodak) Vitros DT 60 11 / DTE 1I system and Vitros ECO, DT Slides for Johnson and Johnson’s Vitros Chemistry Analyzers. Predicate Device 510K number: K912844/A - K903144 Predicate Product Code: -- 75KHS CARESIDE, Inc. CARESIDE™ CO, Premarket Notification Page 11 IV. J… | 1991 |
| * | K903144 | Kodak Ektachem Clinical Chemistry Slides (ECO2)Summary page 1…Eastman Kodak) Vitros DT 60 11 / DTE 1I system and Vitros ECO, DT Slides for Johnson and Johnson’s Vitros Chemistry Analyzers. Predicate Device 510K number: K912844/A - K903144 Predicate Product Code: -- 75KHS CARESIDE, Inc. CARESIDE™ CO, Premarket Notification Page 11 IV. July 23, 1999… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure total CO₂ from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with respiratory and metabolic disorders associated with acid-base imbalance.
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/K992475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992475: Careside CO2, Total.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992475
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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