# K081449: Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Jun 3, 2008 after 11 days
- Product code: MMK (Container, Sharps)
- 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 K021983 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021983: Ulti Guard Home Insulin Syringe Container, Ultimed, Inc. (2002) Summary page 1.

## Indications for use
The UltiGuard H6me Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.

Source page: https://510kreport.com/device/K081449
Methodology: https://510kreport.com/methodology