510(k) · Cleared
Recalled · Class I · 2019CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on May 1, 2019 as substantially equivalent to K171028 (GE Healthcare Finland Oy, 2017) after a 145-day review. Its family tree reaches back 5 generations to 2000. 4 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- May 1, 2019
- Review
- 145 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001814 (2000). 1 later device descends from it, 1 citing it directly. 4 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 4 generations backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- 3 generations backK123195 Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · Recalled (Class I)
- 2 generations backK150245 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO…GE Healthcare Finland Oy · 2015 · Recalled (Class I)
- 1 generation backK171028 CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO…GE Healthcare Finland Oy · 2017 · Recalled (Class I)
- This deviceK183394 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOGE Healthcare Finland Oy · 2019
- Descendant · cites it directly · 0 of its ownK211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO…GE Healthcare Finland Oy · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…GE Healthcare Finland Oy · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −4 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| −3 | K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories | GE Healthcare Finland Oy | 2013 | Class I |
| −2 | K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV… | GE Healthcare Finland Oy | 2015 | Class I |
| −1 | K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV… | GE Healthcare Finland Oy | 2017 | Class I |
| 0 (this device) | K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | GE Healthcare Finland Oy | 2019 | — |
| +1 | K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV… | GE Healthcare Finland Oy | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
4 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? (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 |
|---|---|---|---|
| * | K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and…Summary page 6…(Anesthetic Concentration) Additional Product CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Codes: Predicate Device(s): K171028: CARESCAPE Respiratory Modules, E-sCO, E- sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and… | 2017 |
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 |
|---|---|---|---|
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX… | 2021 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2019 | Class I | Z-0755-2020 | Process control | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. |
| Sep 27, 2019 | Class I | Z-0757-2020 | Process control | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. |
| Sep 27, 2019 | Class I | Z-0754-2020 | Process control | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. |
| Sep 27, 2019 | Class I | Z-0756-2020 | Process control | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. |
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.
- K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy · 2017 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXGE Healthcare Finland Oy · 2015 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 5 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K211171 (GE Healthcare Finland Oy, 2021) has gone furthest, with 0 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. 2019, 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 CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2 VO32) of adult and pediatric patients. When monitoring neonatal…
Read the full statement (103 words)
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2 VO32) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.
These modules are intended for use by qualified medical personnel only.
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/K183394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183394: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183394
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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