510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213427Substantially Equivalent

PRIMED Pediatric Facemask

Primed Medical Products Inc., Edmonton, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213427 is the FDA 510(k) clearance record for PRIMED Pediatric Facemask, a class II device, cleared for Primed Medical Products, 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 Primed Medical Products, Inc., from to . As of , FDA records show no recalls naming K213427.

Clearance record

Decision date
Received
(397 days to decision)
Product code
OXZ Pediatric/Child Facemask
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Primed Medical Products, Inc. 200, 2003-91 St., SW Edmonton,, Edmonton, CA
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