510(k) · Cleared
ClearedModification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · KHS Enzymatic, Carbon-Dioxide
Cleared on Dec 27, 2004 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 27, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK042362 Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17…Diagnostic Chemicals, Ltd. · 2004
- Descendant · cites it directly · 1 of its ownK100289 Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model…Siemens Healthcare Diagnostics · 2010
- Descendant · 2 generations on · 0 of its ownK152085 Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK140248 S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K100289Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781Siemens Healthcare Diagnostics · 2010 · cites it directly1descendant
- K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd. · 2016 · 2 generations on0descendants
- K140248S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042362 | Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50… | Diagnostic Chemicals, Ltd. | 2004 | — |
| +1 | K100289 | Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref… | Siemens Healthcare Diagnostics | 2010 | — |
| +2 | K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | 2016 | — |
| +1 | K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100289 (Siemens Healthcare Diagnostics, 2010) has gone furthest, with 1 descendant of its own.
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 the quantitative determination of carbon dioxide in serum and plasma. For INVITRO diagnostic use. Elevated blood CO 2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide. Decreased blood CO 2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a…
Read the full statement (167 words)
For the quantitative determination of carbon dioxide in serum and plasma. For INVITRO diagnostic use.
Elevated blood CO 2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide.
Decreased blood CO 2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation or stimulation of the respiratory center (1).
Classic techniques for the measurement of carbon dioxide (CO2 ) involve the addition of acid to liberate the carbon dioxide and the measurement of carbon dioxide thus released by either manometric, volumetric, or titrimetric techniques. These procedures are both time consuming and cumbersome. The DCL Carbon Dioxide L3K® assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042362: Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042362
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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