510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954455Substantially Equivalent

Niomed Bouffant Caps

Amerasia Corp., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954455 is the FDA 510(k) clearance record for NIOMED BOUFFANT CAPS, a class I device, cleared for Amerasia Corp. on under FDA product code FYF (Cap, Surgical). FDA records list 6 510(k) clearances for Amerasia Corp., from to . As of , FDA records show no recalls naming K954455.

Clearance record

Decision date
Received
(120 days to decision)
Product code
FYF Cap, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Amerasia Corp. 4121 Tigris Way, Riverside CA
510(k) summary
Statement
Third party review
No

Clearances, product code FYF

Trailing 12 months

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

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