510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003748Substantially Equivalent

Tianxie

Suzhou Tianyi Acupuncture Instruments Co., Ltd., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003748 is the FDA 510(k) clearance record for TIANXIE, a class II device, cleared for Suzhou Tianyi Acupuncture Instruments Co., Ltd. on under FDA product code MQX (Needle, Acupuncture, Single Use). FDA records list one 510(k) clearance for Suzhou Tianyi Acupuncture Instruments Co., Ltd. As of , FDA records show no recalls naming K003748.

Clearance record

Decision date
Received
(53 days to decision)
Product code
MQX Needle, Acupuncture, Single Use
Regulation
21 CFR 880.5580
Device class
Class II
Review panel
General Hospital
Applicant
Suzhou Tianyi Acupuncture Instruments Co., Ltd. 1491 Baker St., Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code MQX

Trailing 12 months

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

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