# K132553: U&U Sterile Piston Syringe Without Needle

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Feb 27, 2014 after 197 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980987 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110771: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2011) Summary page 1.

## Most influential descendants
- K191642: TK Sterile Piston Syringe without Needle (2020), 1 descendant of its own
- K250733: 3DOSE 1ml Syringe (2025), 0 descendants of its own

## Recalls of this device
- Sep 3, 2020 · Class II · Z-0478-2023: Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

## Indications for use
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/injection.

Source page: https://510kreport.com/device/K132553
Methodology: https://510kreport.com/methodology