# K123807: Sharpscan

- Pathway: 510(k) (Traditional)
- Applicant: Medical Engineering Development Solutions, Inc.
- Decided: Jul 23, 2013 after 224 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 K925816 (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)
- K982781: Demolizer #47 One-Gallon Point of Generation Sharps Container, Thermal Waste Technology, Inc. (1998) Summary page 1.

## Indications for use
The sharpsCAN Model 1 Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.

Source page: https://510kreport.com/device/K123807
Methodology: https://510kreport.com/methodology