Pen Injector Needle 32.5— 510(k) K250700

Substantially Equivalent

Terumo Corporation

FDA 510(k) clearance K250700 for Pen Injector Needle 32.5, Substantially Equivalent on 2025-11-21. Applicant: Terumo Corporation.

Clearance details

Applicant: Terumo Corporation
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2025-03-07
Decision date: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shibuya-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.