510(k) · Cleared
ClearedCAPNOSTREAM20 with MICROMEDICO2 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Capnography, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on May 12, 2010 as substantially equivalent to K082268 (Oridion Capnography, Inc., 2009) after a 134-day review. Its family tree reaches back 11 generations to 1997. 2 of the 131 devices in its family, counting itself, have a Class I recall. 93 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K962603 (1997). 37 ancestors in all, the oldest K893221 (1990). 93 later devices descend from it, 8 citing it directly. 2 of the 131 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations between
- 3 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 2 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 1 generation backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- This deviceK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- Descendant · cites it directly · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- Descendant · 2 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 3 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 4 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 4 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
Show all 11 generations
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 9 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 8 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 7 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 6 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 5 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 3 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 2 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 1 generation backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- This deviceK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 93 · See all- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · cites it directly65descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 2 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 3 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 4 generations on24descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −10 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −9 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −8 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −7 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −6 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −5 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −4 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −3 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −2 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −1 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| 0 (this device) | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
| +1 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| +2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +4 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 10 | 1 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 12 | 0 |
| 2023 | 6 | 0 |
| 2024 | 11 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K082268 | CAPNOSTREAM20 with Integrated Pulmonary IndexSummary page 4…Capnostream2O Bedside Predicate Device- Capnostream2O Monitor with Bedside Monitor K082268 microMediCO2CO2 module Indications for The indications for use are identical to The Capnostream2O… | 2009 |
What descends from it? (93)
See all 938 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121013 | Connex Vital Signs Monitor 6000 Series | 2012 | 65 |
| K112432 | Zoll X Series | 2012 | 8 |
| K101995 | Capnostream 20P with Masimo SPO2 Board | 2011 | 7 |
| K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | 2013 | 5 |
| K133961 | Suresigns VS3, Suresigns VS4 | 2014 | 3 |
| K140430 | 740 Select | 2014 | 1 |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | 2019 | 0 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | 2015 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 37 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K121013 (Welch Allyn, Inc., 2012) has gone furthest, with 65 descendants of its own.
- 2 other devices also cite its predicate K082268.
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. 2010, 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 Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO 2 ) and pulse rate- It is intended for use with neonatal, pediatric and adult…
Read the full statement (175 words)
The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide
professionally trained health care providers the continuous, non invasive measurement and
monitoring of carbon dioxide concentration of the expired and inspired breath and respiration
rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SPO 2 ) and pulse rate- It is intended for use with neonatal, pediatric and adult
patients in hospitals, hospital type facilities, intra hospital transport and home environments.
The Capnostreamn20 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 IPI 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. IPI monitoring displays a single value that represents the patient's pulmonary
parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI 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/K094012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094012: CAPNOSTREAM20 with MICROMEDICO2 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094012
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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