# K140949: Ulticare Safety Syringe with Removable Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed Incorporated
- Decided: Feb 9, 2015 after 301 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: 2 generations back to K922522 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080600: Ultimed Ulticare Safety Syringe, Ultimed, Inc. (2008) Summary page 5.
- K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes, Sherwood Medical Co. (1992) Summary page 5.

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

Source page: https://510kreport.com/device/K140949
Methodology: https://510kreport.com/methodology