510(k) · Cleared
Recalled · 2009CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Capnography, Inc. · DQA Oximeter
Cleared on May 4, 2006 as substantially equivalent to K040011 (Oridion, Ltd., 2004) and 5 other predicates after a 115-day review. Its family tree reaches back 8 generations to 1997. 2 of the 285 devices in its family, counting itself, have a Class I recall. 250 later devices descend from it. It has been recalled 3 times.
- Decided
- May 4, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 8 generations to K962603 (1997). 34 ancestors in all, the oldest K893221 (1990). 250 later devices descend from it, 7 citing it directly. 2 of the 285 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- This deviceK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006
- Descendant · cites it directly · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 2 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- Descendant · 4 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- Descendant · 3 generations on · 93 of its ownK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
Showing 5 of 250 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 250 · See all- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · cites it directly197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 2 generations on170descendants
- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 3 generations on155descendants
- K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 4 generations on115descendants
- K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010 · 3 generations on93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −1 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | — |
| +1 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +2 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| +3 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| +4 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| +3 | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 17 | 1 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 11 | 0 |
| 2022 | 24 | 0 |
| 2023 | 16 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 15 | 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K040011 | Polaris 2004 CapnographSummary page 2…and alarms. SUBSTANTIAL EQUIVALENCE INFORMATION * CO 2 Module (MiniMediCO 2) used in legally marketed Predicate Devices: V Oridion Polaris 2004, K04001 1, V CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO 2-V1 K0… | 2004 |
| * | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Summary page 2…V Oridion Polaris 2004, K04001 1, V CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO 2-V1 K050844 V Larsen & Toubro Limited Star 50 Monitoring System K051608 * Pulse Oximeter Module, Sp02 Module (MP100)… | 2005 |
| * | K051608 | Star 50 Monitoring SystemSummary page 2…stems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO 2-V1 K050844 V Larsen & Toubro Limited Star 50 Monitoring System K051608 * Pulse Oximeter Module, Sp02 Module (MP100) used in legally marketed Predicate Devices: , NP… | 2005 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 2…Module (MP100) used in legally marketed Predicate Devices: , NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891 v NPB Oximax N-550, K021090 * Nurse Call v NPB OxiMax Pulse Oximeter System With N-595 Pu… | 2002 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 2…dicate Devices: , NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891 v NPB Oximax N-550, K021090 * Nurse Call v NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891… | 2002 |
| * | K022084 | Atlas Monitor, Models 200,210,220Summary page 2…Nurse Call v NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891 · Welch Allyn Atlas Monitor K022084 CLASSIFICATION Capnostream 20 73CCK Class [I This device has two modules that are classified as follows: * 21 CFR 868.1400,… | 2002 |
What descends from it? (250)
See all 2507 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072295 | Capnostream 20 with A2 Adaptive Averaging Software | 2007 | 197 |
| K083821 | Vital Signs Monitor | 2009 | 39 |
| K093016 | Vital Signs Monitor | 2010 | 16 |
| K100654 | Zoll Propaq MD | 2010 | 11 |
| K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | 2009 | 10 |
| K160582 | WiCap | 2016 | 0 |
| K091787 | Model 6000 Two Parameter Bedside Monitor | 2009 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2009 | Not classified | Z-2232-2009 | Device Design | 1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits… |
| Jul 28, 2007 | Not classified | Z-0177-2008 | Process design | Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall. |
| Jul 28, 2007 | Not classified | Z-0178-2008 | Process design | Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall. |
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 9 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 6 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K072295 (Oridion Capnography, Inc., 2007) has gone furthest, with 197 descendants of its own.
- 3 other devices also cite its predicate K040011.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Capnostream 2 0 is intended for CO 2 and SPO2 indications. The Capnostream 20 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…
Read the full statement (147 words)
The Capnostream 2 0 is intended for CO 2 and SPO2 indications. The Capnostream 20 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 moves and home environments.
The Capnostreamlo is intended for C02 indications only. The Capnostream1 0 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. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060065
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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