# K050134: Icc Insulin Safepro Safety Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Formosa Medical Devices, Inc.
- Decided: Apr 5, 2005 after 74 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 K980580 (1998). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K022063: Safepro Safety Syringe, Formosa Medical Devices, Inc. (2002) Summary page 1.

## Most influential descendants
- K080877: 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2 (2008), 2 descendants of its own
- K093400: 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2 (2010), 1 descendant of its own
- K061055: Careo Safety Syringe for U-100 Insulin (2006), 1 descendant of its own
- K100998: 1ML Unitract 27G X 1/2 Tuberculin Syringe,  Model 132BY2-1 (2010), 0 descendants of its own
- K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML (2007), 0 descendants of its own

## Indications for use
The primary indicated use for the icc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid. The secondary indicated use for the Icc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K050134
Methodology: https://510kreport.com/methodology