# K031830: Safepro Plus Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Formosa Medical Devices, Inc.
- Decided: Aug 5, 2003 after 53 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
Longest line of descent: 1 generation back to K012726 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012726: Prosafe Safety Syringe, Hou-Se Medical, Inc. (2001) Summary page 1.
- (no number) B-D Luer Lok conventional syringe: named in the summary without a submission number
- (no number) VanishPoint syringe: named in the summary without a submission number

## Indications for use
The primary indicated use for the Safepro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the Safepro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K031830
Methodology: https://510kreport.com/methodology