510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160100Substantially Equivalent

Prestige Ameritech Pediatric/Child’s Face mask

Prestige Ameritech, North Richland Hills TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160100 is the FDA 510(k) clearance record for Prestige Ameritech Pediatric/Child’s Face mask, a class II device, cleared for Prestige Ameritech on under FDA product code OXZ (Pediatric/Child Facemask). FDA's definition for product code OXZ reads: "A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare...". FDA records list 6 510(k) clearances for Prestige Ameritech, from to . As of , FDA records show no recalls naming K160100.

Clearance record

Decision date
Received
(262 days to decision)
Product code
OXZ Pediatric/Child Facemask
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Prestige Ameritech 7201 Iron Horse Blvd., North Richland Hills TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXZ

Trailing 12 months

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

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