# K150263: K-Pack II Needle-21G x 2

- Pathway: 510(k) (Special)
- Applicant: Terumo Europe N.V.
- Decided: Apr 1, 2015 after 56 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: 2 generations back to K771203 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984576: K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic Needle) 25G X 1, Model KN-2525RB, K, Terumo Europe N.V. (1999) Summary page 4.
- K001572: Neolus Needle, Terumo Europe N.V. (2000) Summary page 4.

## Indications for use
The 21G x 2” K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K150263
Methodology: https://510kreport.com/methodology