# K234024: HWJECT Auto-disable syringe

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Mar 19, 2024 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K883955 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210464: Auto Disable Syringe, Anhui Tiankang Medical Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
The HWJECT Auto-Disable Syringe is intended for aspiration and injection of fluids. Additionally, it features auto-disable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.

Source page: https://510kreport.com/device/K234024
Methodology: https://510kreport.com/methodology
