# K031741: Medley ETCO2 Module (Includes Accessories), Model 8300

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Feb 9, 2004 after 250 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950387 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer, Spegas Industries, Ltd. (1997) Summary page 1.

## Recalls of this device
- Jul 1, 2019 · Class II · Z-2443-2019: Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
- Nov 12, 2015 · Class II · Z-0455-2016: CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with

## Indications for use
The Medley EtCO 2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2 ), fractional inspired carbon dioxide (FiCO 2 ), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The MedleyT' EtCO 2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

Source page: https://510kreport.com/device/K031741
Methodology: https://510kreport.com/methodology