510(k) · Cleared
ClearedCapnostream™35 Portable Respiratory Monitor (PM35MN)
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 May 1, 2026 as substantially equivalent to K200594 (Oridion Medical 1987, Ltd., 2020) after a 224-day review. Its family tree reaches back 16 generations to 1997. 1 of the 74 devices in its family, counting itself, has a Class I recall.
- Decided
- May 1, 2026
- Review
- 224 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K962603 (1997). 73 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 1 of the 74 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations between
- 3 generations backK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012 · Recalled
- 2 generations backK150272 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · Recalled
- 1 generation backK200594 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020
- This deviceK253030 Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
Show all 16 generations
- Root · 16 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 15 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 14 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 13 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 12 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 11 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 10 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 9 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 8 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 7 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 6 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 5 generations backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- 4 generations backK101995 Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc. · 2011
- 3 generations backK112368 CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd. · 2012 · Recalled
- 2 generations backK150272 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2015 · Recalled
- 1 generation backK200594 Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd. · 2020
- This deviceK253030 Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
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 |
|---|---|---|---|---|---|
| −16 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −15 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −14 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −13 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −12 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −11 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −10 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −9 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −8 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −7 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −6 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −5 | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
| −4 | K101995 | Capnostream 20P with Masimo SPO2 Board | Oridion Capnography, Inc. | 2011 | — |
| −3 | K112368 | CAPNOSTREAM20P with AI/Odi | Oridion Medical 1987, Ltd. | 2012 | 6 |
| −2 | K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2015 | 1 |
| −1 | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | — |
| 0 (this device) | 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 |
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 K251641 GF-310R Multigas Unit (GF-310R)score 13.6 · 7 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 |
|---|---|---|---|
| * | K200594 | Capnostream 35 Portable Respiratory MonitorSummary page 7…Predicate Device Name: Capnostream™ 35 Portable Respiratory Monitor Predicate 510(k): K200594 IV. DEVICE DESCRIPTION The Capnostream™ 35 is a portable, 4-inch color screen monitor designed for non-invasive monitoring… | 2020 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 73 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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 and pulse oximetry monitor indicated for non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (EtCO2), respiration rate (RR), arterial oxygen saturation (SpO2), and pulse rate (PR) in patient populations, including adults, pediatrics, and neonates. The Capnostream ™ 35 monitor is indicated for use by professionally trained health care providers. The Capnostream ™…
Read the full statement (416 words)
The Capnostream ™ 35 monitor is a portable capnograph and pulse oximetry monitor indicated for non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (EtCO2), respiration rate (RR), arterial oxygen saturation (SpO2), and pulse rate (PR) in patient populations, including adults, pediatrics, and neonates. The Capnostream ™ 35 monitor is indicated for use by professionally trained health care providers.
The Capnostream ™ 35 monitor is intended for use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport, unless otherwise noted. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and rotary-wing aircraft.
The Capnostream ™ 35 monitor with Microstream™ capnography and accessories is indicated for continuous non-invasive monitoring of capnography-derived respiratory rate, integrated pulmonary index (IP1), 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 adult patients only.
The Capnostream™ 35 monitor with Nellcor™ pulse oximeter and accessories are indicated for providing spot-check and/or continuous non-invasive monitoring of arterial oxygen saturation (SpO2), pulse rate (PR), pleth-derived respiratory rate, Saturation Pattern Detection (SPD), heart rate variability (HRV), and perfusion index (PI). It is intended for use with patients who are well- or poorly perfused, during both no-motion and motion conditions. The device is intended to maintain accuracy in monitoring conditions in which patient and/or pulse oximetry sensor characteristics may affect measurements, by leveraging patient-specific and sensor-specific information to aid in arterial oxygen saturation calculation.
The Saturation Pattern Detection™ Alert (SPD) parameter is intended to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs for continuous monitoring of adults in hospital, hospital-type facilities, and during intra-hospital transport only.
The Respiration Rate (RR) parameter, when used in conjunction with a NellcorTM Respiration Rate sensor, is intended to be used for spot-check or continuous monitoring of respiration rate in adults in hospital, hospital-type facilities, and during and intra-hospital transport only.
The Heart Rate Variability (HRV) is intended for continuous monitoring of the variability of a patient’s pulse rate. The Heart Rate Variability is intended to analyze the pulse rate provided by the oximeter and provide visualization of trends in the pulse rate and HRV values.
The perfusion index is intended for spot-check or continuous monitoring of peripheral perfusion at the pulse oximetry sensor site and provides the ratio of the pulsatile blood to non-pulsatile or static blood in peripheral tissue.
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/K253030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253030: Capnostream™35 Portable Respiratory Monitor (PM35MN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253030
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026