# K213407: UltiCare Disposable Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed Incorporated
- Decided: Dec 16, 2021 after 58 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: 5 generations back to K051899 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162516: BD Pen Needle, Becton, Dickinson and Company (2016) Summary page 4.

## Most influential descendants
- K220614: MEDOJECT fine Pen Needles (2022), 0 descendants of its own

## Indications for use
The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K213407
Methodology: https://510kreport.com/methodology