510(k) · Cleared
ClearedDatex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 23, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 of the 128 devices in its family, counting itself, have a Class I recall. 127 later devices descend from it.
- Decided
- Aug 23, 2000
- Review
- 69 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
127 later devices descend from it, 4 citing it directly. 10 of the 128 devices in this family, counting this one, have a Class I recall.
- This deviceK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- Descendant · cites it directly · 118 of its ownK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 91 of its ownK103604 Isa CO2, Isa AX+, Isa or+Phasein AB · 2011
- Descendant · 3 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 4 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 5 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K052582 Datex-Ohmeda S/5 Single-Width Airway Module…2 generations on · 2005
- K043276 Datex-Ohmeda S/5TM FM with L-FICU04 and…2 generations on · 2004
- K123195 Carescape Respiratory Modules, E-Sco, E-Scov…2 generations on · 2013
- K150245 CARESCAPE Respiratory Modules, E-sCO, E-sCOV…2 generations on · 2015
Most influential descendants
Showing 5 of 127 · See all- K051092Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…GE Healthcare · 2005 · cites it directly118descendants
- K103604Isa CO2, Isa AX+, Isa or+Phasein AB · 2011 · 2 generations on91descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 3 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 4 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| +1 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| +2 | K103604 | Isa CO2, Isa AX+, Isa or+ | Phasein AB | 2011 | — |
| +3 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +5 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 3 | 1 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 1 |
| 2014 | 6 | 1 |
| 2015 | 7 | 1 |
| 2016 | 5 | 0 |
| 2017 | 5 | 1 |
| 2018 | 4 | 0 |
| 2019 | 9 | 3 |
| 2020 | 7 | 0 |
| 2021 | 5 | 1 |
| 2022 | 13 | 0 |
| 2023 | 6 | 0 |
| 2024 | 15 | 0 |
| 2025 | 14 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
10 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (127)
See all 1274 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov… | 2005 | 118 |
| K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories | 2003 | 13 |
| K081601 | Veo Multigas Monitor for Pocket PC | 2008 | 12 |
| K062754 | Gas Module SE, Model 0998-00-0481-02 | 2006 | 2 |
Has anything in its family been recalled? (10 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.
- K052582Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and AccessoriesGE Healthcare · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXGE Healthcare Finland Oy · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 14 Class I recalls
- K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 14 Class I recalls
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOGE Healthcare Finland Oy · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K051092 (GE Healthcare, 2005) has gone furthest, with 118 descendants of its own.
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 | — |
https://510kreport.com/device/K001814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001814: Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001814
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026