510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894457Substantially Equivalent

Carnation Tracheostomy Masks

Dadsun Corp., Ltd., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894457 is the FDA 510(k) clearance record for CARNATION TRACHEOSTOMY MASKS, a class I device, cleared for Dadsun Corp., Ltd. on under FDA product code BYF (Mask, Oxygen, Low Concentration, Venturi). FDA records list 3 510(k) clearances for Dadsun Corp., Ltd., from to . As of , FDA records show no recalls naming K894457.

Clearance record

Decision date
Received
(87 days to decision)
Product code
BYF Mask, Oxygen, Low Concentration, Venturi
Regulation
21 CFR 868.5600
Device class
Class I
Review panel
Anesthesiology
Applicant
Dadsun Corp., Ltd. P.O. Box 73-30, Taipei, TW
Third party review
No

Clearances, product code BYF

Trailing 12 months

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

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