# K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Apr 12, 2022 after 106 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: 5 generations back to K912563 (1991). 6 ancestors in all.
1 later device descends 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)
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set, Greiner Bio-One Na, Inc. (2018) Summary page 4.

## Most influential descendants
- K232881: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (2023), 0 descendants of its own

## Indications for use
The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Source page: https://510kreport.com/device/K214075
Methodology: https://510kreport.com/methodology