510(k) · Cleared
Recalled · 2009Capnostat 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Novametrix, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Nov 19, 2004 as substantially equivalent to K032971 (Respironics Novametrix, Inc., 2004) after a 56-day review. Its family tree reaches back 2 generations to 1992. 15 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920379 (1992). 4 ancestors in all. 15 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK920379 Novametrix Model 7100 Comb. End Tidal CO2 & Pul OXNovametrix Medical Systems, Inc. · 1992 · Recalled
- 1 generation backK032971 Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · Recalled
- This deviceK042601 Capnostat 5Respironics Novametrix, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK073280 Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK192446 CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK110922 Patient MonitorEdan Instruments, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006 · cites it directly3descendants
- K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly2descendants
- K192446CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd. · 2020 · cites it directly1descendant
- K110922Patient MonitorEdan Instruments, Inc. · 2011 · 2 generations on1descendant
- K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920379 | Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX | Novametrix Medical Systems, Inc. | 1992 | 3 |
| −1 | K032971 | Tidal Wave SP Model 710/715 and 715 | Respironics Novametrix, Inc. | 2004 | 7 |
| 0 (this device) | K042601 | Capnostat 5 | Respironics Novametrix, Inc. | 2004 | — |
| +1 | K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2006 | — |
| +1 | K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020 | — |
| +2 | K110922 | Patient Monitor | Edan Instruments, Inc. | 2011 | 1 |
| +2 | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | Mediana Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
Planning a device in CCK? 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 |
|---|---|---|---|
| * | K032971 | Tidal Wave SP Model 710/715 and 715Summary page 1…CO 2 sensor Classification Name: Class II, 21 C.F.R 868.1400 Predicate Device: Capnostat Ill sensor in Tidal Wave Sp, Model 710/715 [510(k) K032971] Description of Device: The Capnostat 5 C02 sensor is designed for continuous, non-invasive monitoring… | 2004 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | 2006 | 3 |
| K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | 2008 | 2 |
| K192446 | CO2 Mainstream Module | 2020 | 1 |
| K100941 | Infinity Mcable - Mainstream CO2 | 2010 | 1 |
| K171828 | ETCO2 Sensor | 2018 | 0 |
| K151812 | Patient Monitors Various Models | 2016 | 0 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | 2015 | 0 |
| K123797 | NT1D Vital Signs Monitor | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2009 | Not classified | Z-1261-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K062095 (Spacelabs Medical, Inc., 2006) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K032971.
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.
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 intended use of the Capnostat 5 CO 2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042601: Capnostat 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042601
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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