# K152323: Disposable Infusion Needle, Safelock Disposable Infusion Needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Dec 14, 2015 after 119 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891063 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070362: Surflo Winged Infusion Set, Terumo Europe N.V. (2007) Summary page 4.

## Most influential descendants
- K221078: Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (2022), 0 descendants of its own

## Indications for use
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient’s vascular system through the needle inserted into the vein. Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient’s vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.

Source page: https://510kreport.com/device/K152323
Methodology: https://510kreport.com/methodology