# K022063: Safepro Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Formosa Medical Devices, Inc.
- Decided: Aug 29, 2002 after 65 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
No predicates in its family tree.
8 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) B-D Luer Lok syringe: named in the summary without a submission number
- (no number) Retractable Technology, Inc. VanishPoint: named in the summary without a submission number
- (no number) SafePro Safety Syringe: named in the summary without a submission number

## Most influential descendants
- K050134: Icc Insulin Safepro Safety Syringe (2005), 6 descendants of its own
- K080877: 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2 (2008), 2 descendants of its own
- K060208: Careo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, (2006), 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

## Indications for use
The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K022063
Methodology: https://510kreport.com/methodology