# K972452: Ramy Integrated Needle Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Alshifa Medical Syringes Mfg. Co., Ltd.
- Decided: Jul 24, 1997 after 78 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Single use piston syringe used to inject fluids into the body. The device has an integrated attached needle and can be sold for prescription or non-prescription use. The tuberculin syringe is for prescription use and the insulin syringe can be sold for non-prescription use. The syringes are sold sterile and are also non-pyrogenic and non-toxic.

Source page: https://510kreport.com/device/K972452
Methodology: https://510kreport.com/methodology