# K062608: 29G and 30G K-Pack II Needle

- Pathway: 510(k) (Special)
- Applicant: Terumo Europe N.V.
- Decided: Sep 15, 2006 after 10 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). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 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 1.
- K000572: E.N.S.I. Syringe, Tri-Ject Intl. Corp. (2000)
- K012646: Terumo 30 Gauge Hypodermic Needle, Terumo Medical Corp. (2001)

## Most influential descendants
- K082820: K-Pack II Needle - 29G Thin Wall (2008), 9 descendants of its own
- K110850: K-Pack II Needle- 27G & 30G Thin Wall (2011), 5 descendants of its own
- K192057: K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (2019), 2 descendants of its own
- K230951: Terumo Injection Filter Needle (NF-3013RBKE05M) (2023), 1 descendant of its own
- K222681: Altaviz Needle Kit (2022), 1 descendant of its own

## Indications for use
The 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/K062608
Methodology: https://510kreport.com/methodology