510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250700Substantially Equivalent

Pen Injector Needle 32.5

Terumo Corp., Shibuya-Ku, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250700 is the FDA 510(k) clearance record for Pen Injector Needle 32.5, a class II device, cleared for Terumo Corporation on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 34 510(k) clearances for Terumo Corporation, from to . As of , FDA records show no recalls naming K250700.

Clearance record

Decision date
Received
(259 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Terumo Corporation 44-1, 2-Chome, Hatagaya, Shibuya-Ku, Tokyo, JP
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