510(k) · Cleared
Recalled · Class II · 2018CAPNOSTREAM20P with AI/Odi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical 1987, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jul 19, 2012 as substantially equivalent to K101995 (Oridion Capnography, Inc., 2011) after a 337-day review. Its family tree reaches back 13 generations to 1997. 2 of the 55 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 19, 2012
- Review
- 337 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 13 generations to K962603 (1997). 48 ancestors in all, the oldest K853990 (1985). 6 later devices descend from it, 2 citing it directly. 2 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- 1 generation backK101995 Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
- This deviceK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK150272 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK200594 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK253030 Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK213911 Microstream CO2 NanoPodCovidien, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK213518 CARESCAPE CO2 Microstream parameterCovidien, LLC · 2022
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 6 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 5 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 4 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- 1 generation backK101995 Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
- This deviceK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · cites it directly4descendants
- K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020 · 2 generations on1descendant
- K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026 · 3 generations on0descendants
- K213911Microstream CO2 NanoPodCovidien, LLC · 2022 · 2 generations on0descendants
- K213518CARESCAPE CO2 Microstream parameterCovidien, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −6 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −4 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −2 | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
| −1 | K101995 | Capnostream 20P with Masimo SPO2 Board | Oridion Capnography, Inc. | 2011 | — |
| 0 (this device) | K112368 | CAPNOSTREAM20P with AI/Odi | Oridion Medical 1987, Ltd. | 2012 | — |
| +1 | K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2015 | 1 |
| +2 | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | — |
| +3 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026 | — |
| +2 | K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022 | — |
| +2 | K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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.
2 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K101995 | Capnostream 20P with Masimo SPO2 BoardSummary page 2…: Manufacturer Device 510(k) No. Clearance Date Oridion 1987 Medical Ltd Capn ostream20p K101995 January 11, 2011 DEVICE DESCRIPTION The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMe… | 2011 |
| * | — | Capnostream2Op with Masimo MX1 SpO2 board Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2018 | Class II | Z-0022-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Jul 31, 2018 | Class II | Z-0023-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Jul 31, 2018 | Class II | Z-0026-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Jul 31, 2018 | Class II | Z-0027-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Jul 31, 2018 | Class II | Z-0025-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Jul 31, 2018 | Class II | Z-0021-2019 | Nonconforming Material/Component | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
The 5 latest of 6 recalls; the web page lists all.
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.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150272 (Oridion Medical 1987, Ltd., 2015) has gone furthest, with 4 descendants of its own.
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. 2012, 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 Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous…
Read the full statement (203 words)
The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMetISpHb sensor), methemoglobin saturation (measured by an SpCO/SpMetISpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMetISpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport and home environments.
The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IP1 is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1- 10, where 10 indicates optimal pulmonary status. IP1 monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IP1 is an adjunct to, and is not intended to replace, vital sign monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112368 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112368: CAPNOSTREAM20P with AI/Odi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112368
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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