510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K201634Substantially Equivalent

RG 3ml Medication Cartridge

Chengdu Shifeng Medical Technology Co., Ltd., Jinhua Town, Xinjin County, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201634 is the FDA 510(k) clearance record for RG 3ml Medication Cartridge, a class II device, cleared for Chengdu Shifeng Medical Technology Co., Ltd. on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list one 510(k) clearance for Chengdu Shifeng Medical Technology Co., Ltd. As of , FDA records show no recalls naming K201634.

Clearance record

Decision date
Received
(283 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Chengdu Shifeng Medical Technology Co., Ltd. # 31, Yinyuan Rd., Jinhua Town, Xinjin County, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRZ

Trailing 12 months

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

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