510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041079Substantially Equivalent

Guan Hong Ultrasonic Nebulizer, Model Dr-103/Ac-103

Guan Hong Enterprise Co., Ltd., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041079 is the FDA 510(k) clearance record for GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103, a class II device, cleared for Guan Hong Enterprise Co., Ltd. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Guan Hong Enterprise Co., Ltd. As of , FDA records show no recalls naming K041079.

Clearance record

Decision date
Received
(155 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Guan Hong Enterprise Co., Ltd. 3892 S. America W. Trl., Flagstaff AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260