# K994230: Ulticare Disposable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Mar 24, 2000 after 99 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
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) Becton Dickinson MedSaver™ syringe: named in the summary without a submission number

## Most influential descendants
- K033794: Ulticare Disposable Syringe 3 ML/CC (2003), 7 descendants of its own
- 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

## Indications for use
The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, 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/K994230
Methodology: https://510kreport.com/methodology