# K080600: Ultimed Ulticare Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Jun 25, 2008 after 114 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 K922522 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes, Sherwood Medical Co. (1992) Summary page 1.

## Most influential descendants
- K103011: Ulticare Safety Insulin Syringe (2011), 1 descendant of its own
- K150758: Safelock Disposable Insulin Syringe (2015), 0 descendants of its own
- K140949: Ulticare Safety Syringe with Removable Needle (2015), 0 descendants of its own

## Indications for use
UltiMed UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety shield aids in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K080600
Methodology: https://510kreport.com/methodology