510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140516Substantially Equivalent

Terumo Pen Injector Needle 34

Kofu Factory of Terumo Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140516 is the FDA 510(k) clearance record for Terumo Pen Injector Needle 34, a class II device, cleared for Kofu Factory of Terumo Corp. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 4 510(k) clearances for Kofu Factory of Terumo Corp., from to . As of , FDA records show no recalls naming K140516.

Clearance record

Decision date
Received
(158 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Kofu Factory of Terumo Corp. 950 Elkton Blvd., Elkton MD
510(k) summary
Summary PDF
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