# K081821: D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)

- Pathway: 510(k) (Traditional)
- Applicant: Global Pathogen Solutions, Inc.
- Decided: Sep 2, 2008 after 67 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
Longest line of descent: 3 generations back to K964387 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G, Sterilogic Waste Systems, Inc. (2002) Summary page 1.
- K955514: Sharps Safe 1.5 & Sharps Safe 2.0, Dura-Vac Products (1996) Summary page 2.
- K070577: ON the GO Sharps, Medport, Inc. (2007) Summary page 2.

## Indications for use
The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.

Source page: https://510kreport.com/device/K081821
Methodology: https://510kreport.com/methodology