# K183394: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: May 1, 2019 after 145 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001814 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171028: CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories, GE Healthcare Finland Oy (2017) Summary page 6.

## Most influential descendants
- K211171: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (2021), 0 descendants of its own

## Recalls of this device
- Sep 27, 2019 · Class I · Z-0755-2020: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K183394
Methodology: https://510kreport.com/methodology