Pen Injector Needle 32.5
FDA 510(k) K250700 · Terumo Corporation
510(k) numberK250700
Submission
- Device name
- Pen Injector Needle 32.5
- Applicant
- Terumo Corporation
Shibuya-Ku, Tokyo, JP - Received
- March 7, 2025
- Decision date
- November 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was Pen Injector Needle 32.5 cleared by the FDA?
Pen Injector Needle 32.5 (K250700) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 259 days after the submission was received.
What is the product code of K250700?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.