QOHClass II

Extracorporeal System For Carbon Dioxide Removal

21 CFR 870.4150 / Cardiovascular

QOH is the FDA product code for Extracorporeal System For Carbon Dioxide Removal, a class II device type, regulated under 21 CFR 870.4150. FDA's definition for this code reads: "An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2021-11-13, and no recalls.

Classification record

Product code: QOH
Device name: Extracorporeal System For Carbon Dioxide Removal
FDA definition: An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).
Regulation: 21 CFR 870.4150
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QOH

By decision year

1 clearance under product code QOH with a decision year between 2021 and 2021, 2021 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QOH by decision year
Year	Clearances
2021	1

Applicants with the most clearances

Product code QOH

Applicants holding the most 510(k) clearances under product code QOH
Applicant	Clearances
Alung Technologies, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QOH.

Recent clearances

Product code QOH

DEN210006Class IIHemolung Respiratory Assist SystemAlung Technologies, Inc. / cleared 2021-11-13

Recent recalls

Product code QOH

FDA records show no recalls under product code QOH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)