Microstream O2/CO2 Oral Nasal FilterLine

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011536

by Oridion Medical 1987 Ltd.

Identifiers

510(k) Number: K011536 FDA 510(k)
FDA Product Code: CCK FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.1400 FDA 510(k)
Regulation Number: 868.1400 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Microstream O2/CO2 Oral Nasal FilterLine is a CO2 sampling line/airway adapter designed for monitoring end-tidal carbon dioxide (EtCO2) and oxygen delivery in adult patients. It functions as a disposable filter system to ensure accurate gas sampling while minimizing contamination and maintaining patient safety during respiratory monitoring.

This device is supplied as a single-use, non-sterile disposable component intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. It is compatible with capnography systems and adheres to FDA 510(k) clearance (K011536) under the product code CCK, with a special review designation. The FilterLine is part of a recall history noted in the U.S. medical device databases.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oridion Microstream 006912 O2/CO2 Nasal FilterLine - Adult CO2 Nasal ..., Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and ..., Class 2 Device Recall Microstream O2/CO2 NASAL FILTERLINE ADULT, MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE (K011536) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K011536	Class II	Active

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Manufacturer

Manufacturer: Oridion Medical 1987 Ltd.
FDA Applicant: Oridion Medical 1987 , Ltd.

Sources (1)

FDA 510(k) K011536 24 fields · synced Oct 6, 2026