# K150333: MedSource Sharps Dart

- Pathway: 510(k) (Traditional)
- Applicant: Medsource International, LLC
- Decided: May 8, 2015 after 87 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: 2 generations back to K943134 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972279: Sharps Shuttle, Sage Products, Inc. (1997) Summary page 4.
- K140285: B Travelsavvy Sharps Container, Bellegrove Medical Supply, Inc. (2014) Summary page 4.

## Indications for use
The MedSource Sharps Dart is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave. MedSource Sharps Dart Model No. MS-64250 Color-Clear/translucent with red closure Length-17cm (6.7 in.) Diameter-3cm (1.2 in.) Empty Weight- 255 gm ( 0.9 oz)

Source page: https://510kreport.com/device/K150333
Methodology: https://510kreport.com/methodology