510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852627Substantially Equivalent

Maxi-Neb

Ashai Co., Ltd., Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852627 is the FDA 510(k) clearance record for MAXI-NEB, a class I device, cleared for Ashai Co. , Ltd. on under FDA product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)). FDA records list 12 510(k) clearances for Ashai Co. , Ltd., from to . As of , FDA records show no recalls naming K852627.

Clearance record

Decision date
Received
(98 days to decision)
Product code
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation
21 CFR 868.5640
Device class
Class I
Review panel
Anesthesiology
Applicant
Ashai Co. , Ltd. 620 Harris St., Australia, AU
Third party review
No

Clearances, product code CCQ

Trailing 12 months

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

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