# K113673: Mysafety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medicalchain Internartional Corporation
- Decided: Aug 3, 2012 after 234 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
Longest line of descent: 5 generations back to K931367 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111734: Mysafety Syringe, Medicalchain Intl. Corp. (2011) Summary page 1.
- K110421: Disposable Insulin Syringe, Wenzhou Wuzhou Import & Export Co., Ltd. (2011) Summary page 1.

## Indications for use
The Syringe for Insulin is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of insulin into the body.

Source page: https://510kreport.com/device/K113673
Methodology: https://510kreport.com/methodology