510(k) · Cleared
ClearedCarbon Dioxide (CO2), Scal, Nortrol and Abtrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermofisher Scientific OY · KHS Enzymatic, Carbon-Dioxide
Cleared on Oct 5, 2007 as substantially equivalent to K032377 (Roche Diagnostics Corp., 2003) after a 144-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Oct 5, 2007
- Review
- 144 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- 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 deviceK071340 Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY · 2007
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) | K071340 | Carbon Dioxide (CO2), Scal, Nortrol and Abtrol | Thermofisher Scientific OY | 2007 | — |
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 3…Roche Diagnostics Corporation, model Hitachi 911 Roche Diagnostics Corporation item: C02-L (Bicarbonate Liquid) (K032377). G. Substantial equivalence -similarities The Carbon Dioxide (CO2) is substantial… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 4.1 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. 2007, 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?
Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for…
Read the full statement (177 words)
Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer.
Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes
For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
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/K071340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071340: Carbon Dioxide (CO2), Scal, Nortrol and Abtrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071340
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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