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D.A.R.T. Pro Kit (D.A.R.T. Pro Handle and X-Tractor Tip)

by Global Pathogen Solutions, Inc.

510(k) K081821

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081821 Date2 Sep 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MMK
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The D.A.R.T. Pro Kit is a container for sharps, designed for the acquisition, removal, and storage of darts projected from stun guns and lodged in human tissue. It consists of a D.A.R.T. Pro Handle and an X-TRACTOR Tip, which together form a system for safely handling contaminated stun-gun darts.

The device is supplied as a kit and is intended for use in general hospital settings. It is a single-use device, not intended for reuse, and is provided non-sterile. The device has received FDA 510(k) clearance under K081821 and is classified as a Class II medical device under regulation number 880.5570.

Questions

AI-generated answers, 23 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 D.A.R.T. Pro Kit used for?

    The D.A.R.T. Pro Kit is designed for the acquisition, removal, and storage of darts projected from stun guns and lodged in human tissue. It consists of a handle and tip that together form a system to safely handle contaminated stun-gun darts in general hospital settings.

  • Is the D.A.R.T. Pro Kit sterile or non-sterile, and can it be reused?

    The D.A.R.T. Pro Kit is provided non-sterile and is intended for single-use only. It is not designed for reuse, as stated in the device description, to ensure safe handling of contaminated sharps without risk of cross-contamination.

  • What components are included in the D.A.R.T. Pro Kit?

    The D.A.R.T. Pro Kit includes a D.A.R.T. Pro Handle and an X-TRACTOR Tip, which together form a complete system for safely managing stun-gun darts embedded in tissue. These components are supplied as a kit for use in general hospital environments.