510(k) · Cleared
ClearedCapnostream 35 Portable Respiratory Monitor
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 Apr 27, 2020 as substantially equivalent to K150272 (Oridion Medical 1987, Ltd., 2015) and 1 other predicate after a 52-day review. Its family tree reaches back 15 generations to 1997. 1 of the 74 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 27, 2020
- Review
- 52 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K962603 (1997). 72 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 74 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 deviceK200594 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253030 Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
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 deviceK200594 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026 · cites it directly0descendants
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) | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | — |
| +1 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026 | — |
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 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K150272 | Capnostream 35 Portable Respiratory MonitorSummary page 4…21 CFR 868.2375 Breathing frequency monitor Regulatory Class: II Product Code: CCK, DQA, MNR Predicate Devices CapnoStream 35 Portable Respiratory Monitor (K150272) NellCor Bedside Respiratory Patient Monitoring System (K141518) Device Description The Capnostream™35 is a 4-inc… | 2015 |
| * | K141518 | Nellcor Bedside Respiratory Patient Monitoring SystemSummary page 4…roduct Code: CCK, DQA, MNR Predicate Devices CapnoStream 35 Portable Respiratory Monitor (K150272) NellCor Bedside Respiratory Patient Monitoring System (K141518) Device Description The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a mi… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | 2026 | 0 |
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 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253030 (Covidien, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2020, 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™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion and motion conditions and for patients who…
Read the full statement (201 words)
The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion and motion conditions and for patients who are well or poorly perfused.
The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.
The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200594: Capnostream 35 Portable Respiratory Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200594
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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