510(k) · Cleared
Recalled · Class II · 2019Carbon Dioxide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KHS Enzymatic, Carbon-Dioxide
Cleared on May 4, 2006 as substantially equivalent to K032377 (Roche Diagnostics Corp., 2003) after an 87-day review. Its family tree reaches back 5 generations to 1984. It has been recalled once.
- Decided
- May 4, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- KHS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K842280 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 4 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 3 generations backK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- 1 generation backK032377 Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp. · 2003
- This deviceK060295 Carbon DioxideAbbott Laboratories · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −4 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −3 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K032377 | Roche Diagnostics Hitachi Bicarbonate Liquid | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K060295 | Carbon Dioxide | Abbott Laboratories | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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? (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 |
|---|---|---|---|
| * | K032377 | Roche Diagnostics Hitachi Bicarbonate LiquidSummary page 2…Page I Substantial Equivalence: The Carbon Dioxide assay is substantially equivalent to the Carbon Dioxide (CO2L) assay (K032377) on the Hitachi 717 Analyzer. Both assays yield similar Performance Characteristics. Similarities: * Both assays ar… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2019 | Class II | Z-0575-2020 | Under Investigation by firm | Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K032377.
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?
The Carbon Dioxide test system, reagent and calibrator, is a device intended to measure bicarbonate/carbon dioxide in plasma, and serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentiafly serious disorders associated with changes in body acid-base balance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060295: Carbon Dioxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060295
Report an extraction error
Are you the manufacturer?
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