# K110527: K-Pack Surshield Needle, Hypodermic Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Jun 6, 2011 after 102 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 K904198 (1990). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050106: Novofine Autocover 30G X 8MM, Novo Nordisk, Inc. (2005) Summary page 2.
- K051865: Terumo Surguard 2 Safety Needle or Similar, Terumo Medical Corp. (2005)

## Most influential descendants
- K111797: 27 G X 1/2 K-Pack Surshield Needle (2011), 2 descendants of its own
- K243309: 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (2025), 0 descendants of its own
- K223353: DropSafeTM SicuraTM (2022), 0 descendants of its own

## Indications for use
The K-Pack SurshiedTM Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection as well as for injection in infusion lines.

Source page: https://510kreport.com/device/K110527
Methodology: https://510kreport.com/methodology