# K170276: Safety Blood Collection Device for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Gemtier Medical (Shanghai), Inc.
- Decided: Dec 11, 2017 after 315 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 K912563 (1991). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121908: Safety Infusion Set, Greiner Bio-One North America, Inc. (2012) Summary page 5.

## Most influential descendants
- K211293: Safety Winged Blood Collection Sets (2021), 1 descendant of its own
- K243806: Safety Winged Blood Collection Sets (2025), 0 descendants of its own

## Indications for use
The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Source page: https://510kreport.com/device/K170276
Methodology: https://510kreport.com/methodology