# DEN220048: Neoasis

- Pathway: De Novo (Direct)
- Applicant: Invictus Medical, Inc.
- Decided: Jun 16, 2023 after 326 days
- Product code: QWX (Active Noise Attenuation System For Infant Incubators)
- Device class: 2
- Regulation: 21 CFR 880.5405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Neoasis® device is intended to reduce noise levels inside an infant incubator in the neonatal intensive care unit (NICU). The attenuation performance of the device is for noises in the NICU with frequencies between 250 Hz to 1,000 Hz.

Source page: https://510kreport.com/device/DEN220048
Methodology: https://510kreport.com/methodology