510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K905288Substantially Equivalent

Anesthesia/respiratory Face Mask, Various Sizes

Med-Tek Innovations, Inc., Glendale WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905288 is the FDA 510(k) clearance record for ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES, a class I device, cleared for Med-Tek Innovations, Inc. on under FDA product code BYG (Mask, Oxygen). FDA records list 3 510(k) clearances for Med-Tek Innovations, Inc., from to . As of , FDA records show no recalls naming K905288.

Clearance record

Decision date
Received
(134 days to decision)
Product code
BYG Mask, Oxygen
Regulation
21 CFR 868.5580
Device class
Class I
Review panel
Anesthesiology
Applicant
Med-Tek Innovations, Inc. 6685 N. Sidney Pl., Glendale WI
Third party review
No

Clearances, product code BYG

Trailing 12 months

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

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