# K031163: Sez Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sez Corporation
- Decided: Jul 8, 2003 after 85 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 K011754 (2003). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011754: Exel Securetouch PTP Syringe, Exelint Intl. Co. (2003)

## Most influential descendants
- K070117: Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CC (2007), 0 descendants of its own
- K060109: Omi Retractable Safety Syringe (2006), 0 descendants of its own
- K050116: Uniqsafe Rotatable, Retractable Safety Syringes (2005), 0 descendants of its own
- K043419: P&P Safety Syringe (2005), 0 descendants of its own

## Indications for use
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Source page: https://510kreport.com/device/K031163
Methodology: https://510kreport.com/methodology