# K021983: Ulti Guard Home Insulin Syringe Container

- Pathway: 510(k) (Traditional)
- Applicant: Ultimed, Inc.
- Decided: Sep 16, 2002 after 90 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Home Sharps Container: named in the summary without a submission number

## Most influential descendants
- K081449: Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container (2008), 0 descendants of its own

## Indications for use
The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin syringes in the home. After use the used syringe can be placed back into the container for safe storage and eventual disposal according to local regulations

Source page: https://510kreport.com/device/K021983
Methodology: https://510kreport.com/methodology