510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210006Unknown

Hemolung Respiratory Assist System

Alung Technologies, Inc., Pittsburgh PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210006 is the FDA 510(k) clearance record for Hemolung Respiratory Assist System, a class II device, cleared for Alung Technologies, Inc. on under FDA product code QOH (Extracorporeal System For Carbon Dioxide Removal). FDA's definition for product code QOH 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...". FDA records list one 510(k) clearance for Alung Technologies, Inc. As of , FDA records show no recalls naming DEN210006.

Clearance record

Decision date
Received
(254 days to decision)
Product code
QOH Extracorporeal System For Carbon Dioxide Removal
Regulation
21 CFR 870.4150
Device class
Class II
Review panel
Cardiovascular
Applicant
Alung Technologies, Inc. 2500 Jane St., Pittsburgh PA
Third party review
No

Clearances, product code QOH

Trailing 12 months

FDA records hold no clearances under product code QOH in the trailing twelve months.

FDA records show no clearances under product code QOH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QOH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260