510(k) · Cleared
ClearedCARESCAPE CO2 Microstream parameter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 12, 2022 as substantially equivalent to K150272 (Oridion Medical 1987, Ltd., 2015) after a 160-day review. Its family tree reaches back 15 generations to 1997. 1 of the 71 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 12, 2022
- Review
- 160 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K962603 (1997). 70 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations between
- 3 generations backK101995 Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
- 2 generations backK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012 · Recalled
- 1 generation backK150272 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · Recalled
- This deviceK213518 CARESCAPE CO2 Microstream parameterCovidien, LLC · 2022
Show all 15 generations
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 13 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 12 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 11 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 10 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 9 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 8 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 7 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 6 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 5 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 4 generations backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- 3 generations backK101995 Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
- 2 generations backK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012 · Recalled
- 1 generation backK150272 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · Recalled
- This deviceK213518 CARESCAPE CO2 Microstream parameterCovidien, LLC · 2022
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −14 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −13 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −12 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −11 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −10 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −9 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −8 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −7 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −6 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −5 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −4 | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
| −3 | K101995 | Capnostream 20P with Masimo SPO2 Board | Oridion Capnography, Inc. | 2011 | — |
| −2 | K112368 | CAPNOSTREAM20P with AI/Odi | Oridion Medical 1987, Ltd. | 2012 | 6 |
| −1 | K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2015 | 1 |
| 0 (this device) | K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 1 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K150272 | Capnostream 35 Portable Respiratory MonitorSummary page 4…CE Predicate Manufacturer: Oridion Medical 1987 LTD Predicate Trade Name: CapnostreamTM 35 Portable Respiratory Monitor Predicate 510(k): K150272 Covidien llc K213518… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 70 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K150272.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The CARESCAPE™* CQO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.
The CARESCAPE™* CQO2 - Microstream™ parameter is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.
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/K213518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213518: CARESCAPE CO2 Microstream parameter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213518
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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