# K223334: Sterile Hypodermic Needles for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
- Decided: Dec 16, 2022 after 45 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: 8 generations back to K904198 (1990). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211214: Sterile Hypodermic Needles for Single Use, Azur Medical Company, Inc. (2021) Summary page 6.

## Most influential descendants
- K233037: Sterile Hypodermic Needles for Single Use (2023), 0 descendants of its own

## Indications for use
The Sterile Hypodermic Needles for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K223334
Methodology: https://510kreport.com/methodology