# K210464: Auto Disable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Aug 24, 2021 after 189 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: 3 generations back to K883955 (1988). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201234: BD SoloShot Mini Syringe/ BD Auto Disable Syringe, Becton, Dickinson and Company (2020) Summary page 4.

## Most influential descendants
- K234024: HWJECT Auto-disable syringe (2024), 0 descendants of its own
- K231519: Revital Cady (2023), 0 descendants of its own

## Indications for use
The AUTO DISABLE SYRINGE is intended for use in the suction and injection of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.

Source page: https://510kreport.com/device/K210464
Methodology: https://510kreport.com/methodology