510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221472Substantially Equivalent

Filter and HME/Filter

Ningbo Huakun Medical Equipment Co.,Ltd, Cixi, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K221472 is the FDA 510(k) clearance record for Filter and HME/Filter, a class II device, cleared for Ningbo Huakun Medical Equipment Co., Ltd. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list one 510(k) clearance for Ningbo Huakun Medical Equipment Co., Ltd. As of , FDA records show no recalls naming K221472.

Clearance record

Decision date
Received
(264 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Ningbo Huakun Medical Equipment Co., Ltd. #208 Binjiang Rd.,, Cixi, CN
510(k) summary
Statement
Third party review
No

Clearances, product code CAH

Trailing 12 months
2 clearances under product code CAH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260