# K033794: Ulticare Disposable Syringe 3 ML/CC

- Pathway: 510(k) (Special)
- Applicant: Ultimed, Inc.
- Decided: Dec 30, 2003 after 25 days
- Product code: FMF (Syringe, Piston)
- 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 K941095 (1994). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994230: Ulticare Disposable Syringe, Ultimed, Inc. (2000) Summary page 1.
- K941095: Medsaver Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Most influential descendants
- K062702: Ulticare Disposable Syringes and Needles (2006), 6 descendants of its own
- K070917: Feel-Ject Insulin Syringe (2007), 5 descendants of its own
- K091474: Easy.Touch Insulin Syringe (2009), 1 descendant of its own
- K152803: Sungshim Sterile Single Use Insulin Syringe (2016), 0 descendants of its own
- K122787: Comfort EZ (2012), 0 descendants of its own

## Indications for use
The UltiCare Disposable Syringe is used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

Source page: https://510kreport.com/device/K033794
Methodology: https://510kreport.com/methodology