# K030604: Perfect Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Perfect Medical Industry Co., Ltd.
- Decided: Apr 30, 2004 after 430 days
- Product code: MEG (Syringe, Antistick)
- 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
The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.

Source page: https://510kreport.com/device/K030604
Methodology: https://510kreport.com/methodology