510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254273Substantially Equivalent

Verisafe Safety Sterile Needles (SSN)

Promisemed Hangzhou Meditech Co.,Ltd., Hangzhou City, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K254273 is the FDA 510(k) clearance record for Verisafe Safety Sterile Needles (SSN), a class II device, cleared for Promisemed Hangzhou Meditech Co., Ltd. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 35 510(k) clearances for Promisemed Hangzhou Meditech Co., Ltd., from to . As of , FDA records show no recalls naming K254273.

Clearance record

Decision date
Received
(107 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Promisemed Hangzhou Meditech Co., Ltd. # 1388 Cangxing St., Cangqian Community,Yuhang District, Hangzhou City, CN
510(k) summary
Statement
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260