# 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

- Pathway: 510(k) (Special)
- Applicant: Terumo Europe N.V.
- Decided: Oct 11, 2019 after 71 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.
2 later devices descend from it; 1 cites it directly.
0 of 11 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 6.
- K110850: K-Pack II Needle- 27G & 30G Thin Wall, Terumo Europe N.V. (2011) Summary page 6.

## Most influential descendants
- K230951: Terumo Injection Filter Needle (NF-3013RBKE05M) (2023), 1 descendant of its own
- K242073: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (2024), 0 descendants of its own

## Indications for use
The K-Pack II Needles - 27G x 1/2” Extra Thin Wall, 27G x 1/2” Ultra Thin Wall, 30G x 1/2” Extra Thin Wall and 30G x 1/2” Ultra Thin Wall being Hypodermic Single Lumen Needles are sterile medical devices 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/K192057
Methodology: https://510kreport.com/methodology