510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990037Substantially Equivalent

Neptune Waste Management System

American Immuno Tech, Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990037 is the FDA 510(k) clearance record for NEPTUNE WASTE MANAGEMENT SYSTEM, a class II device, cleared for American Immuno Tech on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list one 510(k) clearance for American Immuno Tech. As of , FDA records show 2 recalls naming K990037.

Clearance record

Decision date
Received
(230 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Immuno Tech 320 Kalmus Dr., Costa Mesa CA
510(k) summary
Summary
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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