# K062702: Ulticare Disposable Syringes and Needles

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Nov 29, 2006 after 79 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941657 (1994). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 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.
- K033794: Ulticare Disposable Syringe 3 ML/CC, Ultimed, Inc. (2003) Summary page 1.
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 1.

## Most influential descendants
- 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
- K102178: Easy Touch (2010), 0 descendants of its own

## Recalls of this device
- Feb 5, 2010 · Not classified · Z-1217-2010: UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.

## Indications for use
The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin. The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are 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/K062702
Methodology: https://510kreport.com/methodology