Skip to content

Fitpack

by Asp Plastics Pty, Ltd. United States 510(k)

510(k) K060037

Product code MMK

Overview

The Fitpack is a sharps container designed for the storage of used and unused syringes. It functions as a sealed, injection-molded, and tamper-resistant disposal container.

This device is regulated under FDA 510(k) clearance as a class 2 medical device. It is intended for use in general hospital settings to assist in the containment of sharps.

Summary written by AI from registry data, 22 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060037 Date25 Jul 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MMK
FDA applicant
Asp Plastics Pty , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the primary purpose of the Fitpack?

    The Fitpack is designed to assist in the containment of sharps within general hospital settings. It provides a secure, tamper-resistant environment for the storage of both used and unused syringes.

  • How is the Fitpack constructed?

    The device is an injection-molded, sealed container. This construction method is used to ensure the unit is tamper-resistant, which is necessary for the safe disposal and containment of medical sharps.

  • What is the regulatory status of this device?

    The Fitpack is regulated as a class 2 medical device and has received FDA 510(k) clearance. It is classified under regulation number 880.5570 for sharps containers.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K060037 24 fields · synced 22 Oct 2026