Not Cleared Direct

DEN220048 - Neoasis (FDA 510(k) Clearance)

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

DEN220048 · Invictus Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
326d
Days
Class 2
Risk

DEN220048 is an FDA 510(k) submission (not cleared) for the Neoasis. Classified as Active Noise Attenuation System For Infant Incubators (product code QWX), Class II - Special Controls.

Submitted by Invictus Medical, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on June 16, 2023 after a review of 326 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5405 - 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 326 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 Invictus Medical, Inc. devices

Submission Details

510(k) Number DEN220048 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 25, 2022
Decision Date June 16, 2023
Days to Decision 326 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 128d · This submission: 326d
Pathway characteristics

Device Classification

Product Code QWX Active Noise Attenuation System For Infant Incubators
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5405
Definition A Device System Which Captures The Environmental Noise And Outputs Noise Cancelling Acoustic Sound Waves To Attenuate Noise In Infant Incubators In The Healthcare Environment.
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.