# K100812: Ulticare Disposable Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Jun 3, 2010 after 72 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: 3 generations back to K973899 (1997). 7 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 17 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.
- K063466: Top Fine, Daejin Tech Medical Manufacturing Co., Ltd. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K1031200: Becton Dickinson B-D Ultra-Fine Original Pen Needles (29 gauge x 1/2"). Number could not be read Summary page 1.

## Most influential descendants
- K113186: Sterile Insulin Pen Needle (2012), 4 descendants of its own
- K133100: Carefine Pen Needle (2014), 3 descendants of its own
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles (2022), 1 descendant of its own
- K152877: SureFine Pen Needle (2016), 1 descendant of its own
- K140568: Carefine Pen Needle with Quintapoint and Superpoint (2014), 1 descendant of its own

## 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/K100812
Methodology: https://510kreport.com/methodology