510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945482Substantially Equivalent

Disposable, CPAP Oxygen Mask

Fvtnks, Sturgis MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945482 is the FDA 510(k) clearance record for DISPOSABLE, CPAP OXYGEN MASK, a class I device, cleared for Fvtnks on under FDA product code BYG (Mask, Oxygen). FDA records list 4 510(k) clearances for Fvtnks, from to . As of , FDA records show no recalls naming K945482.

Clearance record

Decision date
Received
(315 days to decision)
Product code
BYG Mask, Oxygen
Regulation
21 CFR 868.5580
Device class
Class I
Review panel
Anesthesiology
Applicant
Fvtnks 67920 Klinger Lake Rd., Sturgis MI
510(k) summary
Statement
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