510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060082Substantially Equivalent

Tianjin Medis Disposable Infusion Set

Tianjin Medis International Trade Co., Ltd., Hexi District, Tianjin, CN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K060082 is the FDA 510(k) clearance record for TIANJIN MEDIS DISPOSABLE INFUSION SET, a class II device, cleared for Tianjin Medis International Trade Co., Ltd. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Tianjin Medis International Trade Co., Ltd. As of , FDA records show no recalls naming K060082.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Tianjin Medis International Trade Co., Ltd. Wanshun Garden C 1801, Hexi District, Tianjin, CN
510(k) summary
Statement
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260