510(k) · Cleared
Recalled · Class I · 2019Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Feb 28, 2013 as substantially equivalent to K051092 (GE Healthcare, 2005) after a 140-day review. Its family tree reaches back 2 generations to 2000. 5 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.
- Decided
- Feb 28, 2013
- Review
- 140 days
- Class
- Class II
- Product code
- CCL
- Recalls
- 4 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001814 (2000). 13 later devices descend from it, 2 citing it directly. 5 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 1 generation backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- This deviceK123195 Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013
- Descendant · cites it directly · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK171580 Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 4 of its ownK143676 B40i Patient MonitorGE Healthcare Finland Oy · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · cites it directly8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 2 generations on7descendants
- K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 3 generations on5descendants
- K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd. · 2017 · 4 generations on4descendants
- K143676B40i Patient MonitorGE Healthcare Finland Oy · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories | GE Healthcare Finland Oy | 2013 | — |
| +1 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +2 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| +3 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 1 |
| +4 | K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017 | 1 |
| +3 | K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
5 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 |
|---|---|---|---|
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 2…us-phase (Anesthetic cone) Product Code: CCK, CCL, BZK, CAP, CBR, CBQ, CBS, NHO, NHQ, NHP Predicate Device(s): K05 1092: Datex-Ohmeda S5 M Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CaiOV, E-CaiO, E-… | 2005 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Aug 8, 2014 | Class II | Z-2617-2014 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units. |
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.
- 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
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- 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
- 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
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K130584 (Ge Medical Systems China Co., Ltd., 2013) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K051092.
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. 2013, this device’s year, is highlighted.
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 CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (C02, 02, N20, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal 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 as stated in the FDA summary.
https://510kreport.com/device/K123195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123195: Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123195
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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