# K132552: U&U Sterile Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Nov 13, 2013 after 91 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: 3 generations back to K931367 (1993). 10 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 1.

## Most influential descendants
- K142765: TM Safety Needle (2015), 4 descendants of its own
- K191644: TK Safety Needle (2020), 3 descendants of its own
- K231723: Sterile Safety Hypodermic Needles for Single Use (2023), 0 descendants of its own
- K220603: Disposable Medical Safety Hypodermic Needle (2022), 0 descendants of its own
- K213535: Sterile Safety Hypodermic Needles for Single Use (2022), 0 descendants of its own

## Indications for use
U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K132552
Methodology: https://510kreport.com/methodology