510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202831Substantially Equivalent

The iMask Child's Face Mask

Pac-Dent Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K202831 is the FDA 510(k) clearance record for The iMask Child's Face Mask, a class II device, cleared for Pac-Dent, Inc. 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 8 510(k) clearances for Pac-Dent, Inc., from to . As of , FDA records show no recalls naming K202831.

Clearance record

Decision date
Received
(335 days to decision)
Product code
OXZ Pediatric/Child Facemask
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Pac-Dent, Inc. 670 Endeavor Cir., Brea CA
510(k) summary
Statement
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