# K231519: Revital Cady

- Pathway: 510(k) (Traditional)
- Applicant: Revital Healthcare (Epz) Limited
- Decided: Nov 6, 2023 after 165 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: 8 generations back to K904198 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 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 6.
- K211214: Sterile Hypodermic Needles for Single Use, Azur Medical Company, Inc. (2021) Summary page 6.

## Indications for use
Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.

Source page: https://510kreport.com/device/K231519
Methodology: https://510kreport.com/methodology