K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)— 510(k) K251447

Substantially Equivalent

Terumo Europe N.V.

FDA 510(k) clearance K251447 for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB), Substantially Equivalent on 2025-07-08. Applicant: Terumo Europe N.V..

Clearance details

Applicant: Terumo Europe N.V.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2025-05-09
Decision date: 2025-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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.