# K050464: Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: May 11, 2005 after 77 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K002938 (2000). 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)
- K002938: B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 1.
- K031200: Modification to BD Ultra-Fine Iii Pen Needle, Becton, Dickinson & CO (2003) Summary page 1.

## Indications for use
The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K050464
Methodology: https://510kreport.com/methodology