510(k) · Cleared
ClearedS Test Reagent Cartridge Carbon Dioxide (CO2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on Mar 11, 2014 as substantially equivalent to K042362 (Diagnostic Chemicals, Ltd., 2004) after a 40-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Mar 11, 2014
- Review
- 40 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042362 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042362 Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17…Diagnostic Chemicals, Ltd. · 2004
- This deviceK140248 S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042362 | Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50… | Diagnostic Chemicals, Ltd. | 2004 | — |
| 0 (this device) | K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K042362 | Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…Summary page 1…Product Code KHS 807.92 (a)(3): Identification of the legally marketed predicate devices Carbon Dioxide L3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362 807.92 (a)(4): Device Description The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for us… | 2004 |
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.
- 1 other device also cites its predicate K042362.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The S TESTI Reagent Cartridge Carbon Dioxide (C02) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the HITACHI Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The S TEST Reagent Cartridge Carbon Dioxide (C02) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140248: S Test Reagent Cartridge Carbon Dioxide (CO2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140248
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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