510(k) · Cleared
ClearedD.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Pathogen Solutions, Inc. · MMK Container, Sharps
Cleared on Sep 2, 2008 as substantially equivalent to K020664 (Sterilogic Waste Systems, Inc., 2002) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 2, 2008
- Review
- 67 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K964387 (1997). 9 ancestors in all, the oldest K931664 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- 2 generations backK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- 1 generation backK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- This deviceK081821 D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964387 | Point of Use II Sharps-a-Gator | Graphic Controls Corp. | 1997 | — |
| −2 | K991612 | Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G | Sterilogic Waste Systems, Inc. | 1999 | — |
| −1 | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | Sterilogic Waste Systems, Inc. | 2002 | — |
| 0 (this device) | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3GSummary page 1…ideration of the limited and specific use of the device for stun gun dart removal: *Sterilogic Waste Systems, Inc. SteriSharpTM Sharps Disposal Containers (K020664) Global Pathogen Solutions Inc. Page 5-1 5… | 2002 |
| * | K955514 | Sharps Safe 1.5 & Sharps Safe 2.0Summary page 2…utions Inc. Page 5-1 5 10(k) SUMMARY * Dura-Vac Sharps Safe (K955514) * MedPort, LLC On the Go Sharps Transport and Disposal with Safe LockTM (K070577) Device Description: The reusa… | 1996 |
| * | K070577 | ON the GO SharpsSummary page 2…5 10(k) SUMMARY * Dura-Vac Sharps Safe (K955514) * MedPort, LLC On the Go Sharps Transport and Disposal with Safe LockTM (K070577) Device Description: The reusable D.A.R.T. Pro Handle and detachable, single-use only X-TRACTOR Tip (including a safety cap) com… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K020664.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081821: D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081821
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026