510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853266Substantially Equivalent

Plastic Mouth Barrier Hsv-I

Westmark Enterprises, Inc., Skokie IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853266 is the FDA 510(k) clearance record for PLASTIC MOUTH BARRIER HSV-I, a class I device, cleared for Westmark Enterprises, Inc. on under FDA product code BYP (Mouthpiece, Breathing). FDA records list 3 510(k) clearances for Westmark Enterprises, Inc., from to . As of , FDA records show no recalls naming K853266.

Clearance record

Decision date
Received
(85 days to decision)
Product code
BYP Mouthpiece, Breathing
Regulation
21 CFR 868.5620
Device class
Class I
Review panel
Anesthesiology
Applicant
Westmark Enterprises, Inc. 8710 Trumbull Ave., Skokie IL
Third party review
No

Clearances, product code BYP

Trailing 12 months

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

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