# K243581: K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Apr 4, 2025 after 141 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: 5 generations back to K771203 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110850: K-Pack II Needle- 27G & 30G Thin Wall, Terumo Europe N.V. (2011) Summary page 6.

## Indications for use
The K-Pack Enhance Needle a sterile, hypodermic needle, for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The K-Pack Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.

Source page: https://510kreport.com/device/K243581
Methodology: https://510kreport.com/methodology