Not Cleared Direct

DEN210006 - Hemolung Respiratory Assist System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210006 · Alung Technologies, Inc. · Cardiovascular device
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Nov 2021
Decision
254d
Days
Class 2
Risk

DEN210006 is an FDA 510(k) submission (not cleared) for the Hemolung Respiratory Assist System. Classified as Extracorporeal System For Carbon Dioxide Removal (product code QOH), Class II - Special Controls.

Submitted by Alung Technologies, Inc. (Pittsburgh, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2021 after a review of 254 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 254 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Alung Technologies, Inc. devices

Submission Details

510(k) Number DEN210006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 04, 2021
Decision Date November 13, 2021
Days to Decision 254 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics

Device Classification

Product Code QOH Extracorporeal System For Carbon Dioxide Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4150
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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.