510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K131646Substantially Equivalent

Disposable Infusion Set

Shanghai Jinta Medical Co., Ltd., Fengjing Town, Jinshan District, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131646 is the FDA 510(k) clearance record for DISPOSABLE INFUSION SET, a class II device, cleared for Shanghai Jinta Medical Co., Ltd. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list one 510(k) clearance for Shanghai Jinta Medical Co., Ltd. As of , FDA records show no recalls naming K131646.

Clearance record

Decision date
Received
(174 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Shanghai Jinta Medical Co., Ltd. # 18, Jianding Rd., Fengjing Town, Jinshan District, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260