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
K800440Substantially Equivalent

Sterile Sponge Bowls

Premium Plastics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800440 is the FDA 510(k) clearance record for STERILE SPONGE BOWLS, a class I device, cleared for Premium Plastics, Inc. on under FDA product code FNY (Basin, Emesis). FDA records list 9 510(k) clearances for Premium Plastics, Inc., from to . As of , FDA records show no recalls naming K800440.

Clearance record

Decision date
Received
(61 days to decision)
Product code
FNY Basin, Emesis
Regulation
21 CFR 880.6730
Device class
Class I
Review panel
General Hospital
Applicant
Premium Plastics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FNY

Trailing 12 months

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

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