# 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

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Kangbao Medical Equipment Co., Ltd.
- Decided: Dec 22, 2023 after 95 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K912563 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193074: Bevel Up Holder, Nsp Tech Pte, Ltd. (2020) Summary page 6.
- K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder), Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (2022) Summary page 6.

## Indications for use
Winged Infusion Set is indicated for 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. Safety Winged Infusion Set is indicated for 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. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Blood Collection Set is indicated for venous blood collection. 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. Safety Blood Collection set with Holder is indicated for venous blood collection. 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. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.

Source page: https://510kreport.com/device/K232881
Methodology: https://510kreport.com/methodology