# K181508: U&U Blood Collection Sets

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Feb 13, 2019 after 251 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: 4 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102010: Vacuette Premium Safety Blood Collection Set, Medpro Safety Products, Inc. (2010) Summary page 4.

## Indications for use
The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.

Source page: https://510kreport.com/device/K181508
Methodology: https://510kreport.com/methodology