# K163093: Safety Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Shenli Medical Production Co., Ltd.
- Decided: Mar 14, 2017 after 130 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: 1 generation back to K123987 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123987: Improve Blood Collection Set and Improsafe Blood Collection Set, Innovative Medical Technologies, Inc. (2013) Summary page 4.

## Indications for use
The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

Source page: https://510kreport.com/device/K163093
Methodology: https://510kreport.com/methodology