# K151398: K-Pack II Needle - 29G x 5/16 Thin Wall

- Pathway: 510(k) (Special)
- Applicant: Terumo Europe N.V.
- Decided: Jun 25, 2015 after 30 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: 4 generations back to K771203 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K082820: K-Pack II Needle - 29G Thin Wall, Terumo Europe N.V. (2008) Summary page 4.

## Indications for use
The 29G x 5/16” Thin Wall 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/K151398
Methodology: https://510kreport.com/methodology