510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050999Substantially Equivalent

Yi Xin Sterile Syringe for Single Use

Jiangxi Sanxin (Eversincere) Medical Devices Group, Nanchang, Jiangxi, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K050999 is the FDA 510(k) clearance record for YI XIN STERILE SYRINGE FOR SINGLE USE, a class II device, cleared for Jiangxi Sanxin (Eversincere) Medical Devices Group on under FDA product code FMF (Syringe, Piston). FDA records list 2 510(k) clearances for Jiangxi Sanxin (Eversincere) Medical Devices Group, from to . As of , FDA records show 3 recalls naming K050999.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Jiangxi Sanxin (Eversincere) Medical Devices Group Shanjiang Rd., Nanchang, Jiangxi, CN
510(k) summary
Statement
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260