# K190824: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Bluepoint Medical GmbH & Co. KG
- Decided: Dec 18, 2019 after 261 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001814 (2000). 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)
- 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, GE Healthcare (2005) Summary page 4.

## Indications for use
The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours. The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where anesthetic agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport. The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors. The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only.

Source page: https://510kreport.com/device/K190824
Methodology: https://510kreport.com/methodology