# K070117: Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CC

- Pathway: 510(k) (Traditional)
- Applicant: Dolomite Biotech Sdn Bhd
- Decided: Aug 6, 2007 after 206 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: 2 generations back to K011754 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031163: Sez Safety Syringe, Sez Corporation (2003) Summary page 1.

## Indications for use
The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.

Source page: https://510kreport.com/device/K070117
Methodology: https://510kreport.com/methodology