# K251447: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Jul 8, 2025 after 60 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904198 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212095: SurGuard3 Safety Hypodermic Needle, Terumo Europe N.V. (2022) Summary page 5.

## Indications for use
Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick. Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).

Source page: https://510kreport.com/device/K251447
Methodology: https://510kreport.com/methodology