# K060037: Fitpack

- Pathway: 510(k) (Traditional)
- Applicant: Asp Plastics Pty, Ltd.
- Decided: Jul 25, 2006 after 200 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K252637: Community Containers (Flap and Daisy) (2025), 0 descendants of its own

## Indications for use
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes. The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of I ml insulin hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used I ml insulin hypodermic needles and syringes. The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of I ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used I ml and 2 ml hypodermic needles and syringes.

Source page: https://510kreport.com/device/K060037
Methodology: https://510kreport.com/methodology