510(k) · Cleared
Recalled · Class II · 2015Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on May 25, 2005 as substantially equivalent to K001814 (Datex-Ohmeda, 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 8 of the 120 devices in its family, counting itself, have a Class I recall. 118 later devices descend from it. It has been recalled 2 times.
- Decided
- May 25, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- CCL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001814 (2000). 118 later devices descend from it, 8 citing it directly. 8 of the 120 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- This deviceK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005
- Descendant · cites it directly · 91 of its ownK103604 Isa CO2, Isa AX+, Isa or+Phasein AB · 2011
- Descendant · 2 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 3 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 4 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 4 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 118 · See all- K103604Isa CO2, Isa AX+, Isa or+Phasein AB · 2011 · cites it directly91descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 2 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 3 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 4 generations on24descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| 0 (this device) | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | — |
| +1 | K103604 | Isa CO2, Isa AX+, Isa or+ | Phasein AB | 2011 | — |
| +2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +4 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 1 |
| 2014 | 6 | 1 |
| 2015 | 6 | 1 |
| 2016 | 5 | 0 |
| 2017 | 5 | 1 |
| 2018 | 3 | 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), 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.
8 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 CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 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 |
|---|---|---|---|
| * | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and AccessoriesSummary page 2…act Airway Module family, E-CAiOVX is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- CAiOVX Module (K001814). 4 DEVICE DESCRIPTION as required by 807.92(a( _) The Datex-Oh… | 2000 |
What descends from it? (118)
See all 1188 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103604 | Isa CO2, Isa AX+, Isa or+ | 2011 | 91 |
| K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | 2005 | 16 |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories Class I | 2013 | 13 |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX Class I | 2015 | 3 |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | 2006 | 3 |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling… | 2019 | 0 |
| K093080 | Metaphor Metabolic Monitor | 2010 | 0 |
| K062324 | Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG… | 2006 | 0 |
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2015 | Class II | Z-1680-2015 | Nonconforming Material/Component | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a… |
| May 23, 2014 | Class II | Z-1808-2014 | Nonconforming Material/Component | Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring.… |
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.
- K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · Cites it directly · ◆ 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 · Cites it directly · ◆ 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 14 Class I recalls
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOGE Healthcare Finland Oy · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Datex-Ohmeda S/5 MT Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient's respiration (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption V02, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N20+02 mixtures. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051092
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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