# K103011: Ulticare Safety Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ulti-Med Intl., Inc.
- Decided: Feb 2, 2011 after 113 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 1.
- K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes, Sherwood Medical Co. (1992) Summary page 1.

## Most influential descendants
- K150758: Safelock Disposable Insulin Syringe (2015), 0 descendants of its own

## Indications for use
The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K103011
Methodology: https://510kreport.com/methodology