Not Cleared Post-NSE

DEN080009 - AIRPURGE (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN080009 · Anesthesia Safety Products, LLC · General Hospital
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Mar 2014
Decision
1952d
Days
Class 2
Risk

DEN080009 is an FDA 510(k) submission (not cleared) for the AIRPURGE. Classified as Intravascular Administration Set, Automated Air Removal System (product code OKL), Class II - Special Controls.

Submitted by Anesthesia Safety Products, LLC (Woburn, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2014 after a review of 1952 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5445 - the FDA general hospital device 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. High predicate equivalence gap. With 1952 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.

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Submission Details

510(k) Number DEN080009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 29, 2008
Decision Date March 04, 2014
Days to Decision 1952 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1824d slower than avg
Panel avg: 128d · This submission: 1952d
Pathway characteristics

Device Classification

Product Code OKL Intravascular Administration Set, Automated Air Removal System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5445
Definition An Intravascular Administration Set, Automated Air Removal System Is A Prescription Device Used To Detect And Automatically Remove Air From An Intravascular Administration Set With Minimal To No Interruption In The Flow Of The Iv Fluid.
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 General Hospital devices follow this clearance model.