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Disintegrator Insulin Needle Destruction Device

by Redhawk Medical Products & Services, LLC

PMA P010040

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P010040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP010040 Date15 Mar 2002DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
The Disintegrator Plus Lance/Insulin Needle Destructon Device
Trade Name
The Disintegrator Insulin Needle Destruction Device
Generic Name
Sharps needle destruction device
PMA Number
FDA Product Code
MTV
Device Class
Class II
Regulation
21 CFR Part 880.6210
Advisory Committee
General Hospital
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Sharps needle destruction device (generic name) designed to safely destroy used insulin needles and lances. It mechanically disintegrates the needle components into small, non-sharp fragments, reducing the risk of accidental needle-stick injuries and ensuring proper disposal for home use.

The device is intended for single-use in home settings and has received FDA_PMA approval under PMA number P010040. It is classified as a Class II medical device (regulation number 880.6210) and is supplied as a standalone unit for individual patient use. No sterility or MRI safety information is specified.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of The Disintegrator Plus Lance/Insulin Needle Destruction Device?

    This device is designed to safely destroy used insulin needles and lances by mechanically disintegrating them into small, non-sharp fragments, reducing the risk of accidental needle-stick injuries and ensuring proper disposal for home use.

  • How is The Disintegrator Plus device supplied?

    The device is supplied as a standalone unit for individual patient use, intended for single-use in home settings.

  • What is the regulatory status of The Disintegrator Plus device?

    The device has received FDA_PMA approval under PMA number P010040 and is classified as a Class II medical device with regulation number 880.6210.

  • Is The Disintegrator Plus device reusable or single-use?

    The device is intended for single-use in home settings, meaning it should be used once and then disposed of properly.

  • What type of needles and lances can be used with The Disintegrator Plus device?

    The device is specifically designed for insulin needles and lances, as indicated in its approval for insulin needle destruction for home use.