510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220048Unknown

Neoasis

Invictus Medical, Inc., San Antonio TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN220048 is the FDA 510(k) clearance record for Neoasis, a class II device, cleared for Invictus Medical, Inc. on under FDA product code QWX (Active Noise Attenuation System For Infant Incubators). FDA's definition for product code QWX reads: "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". FDA records list 2 510(k) clearances for Invictus Medical, Inc., from to . As of , FDA records show no recalls naming DEN220048.

Clearance record

Decision date
Received
(326 days to decision)
Product code
QWX Active Noise Attenuation System For Infant Incubators
Regulation
21 CFR 880.5405
Device class
Class II
Review panel
General Hospital
Applicant
Invictus Medical, Inc. 16601 Blanco Rd., Suite 120, San Antonio TX
Third party review
No

Clearances, product code QWX

Trailing 12 months

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

FDA records show no clearances under product code QWX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWX, 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