# K181467: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Feb 8, 2019 after 249 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950387 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980324: Microstream Fillerline or/Ems, Oridion Medical, Ltd. (1998) Summary page 4.

## Recalls of this device
- Apr 7, 2025 · Class II · Z-1722-2025: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
- Feb 17, 2025 · Class II · Z-1380-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1377-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1385-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1376-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1381-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1379-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1382-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1383-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1384-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 
- Feb 17, 2025 · Class II · Z-1378-2025: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from 

## Indications for use
Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

Source page: https://510kreport.com/device/K181467
Methodology: https://510kreport.com/methodology