# K182235: OnSite Waste Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Bluestone Medical, Inc.
- Decided: May 20, 2019 after 276 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 K925816 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131708: Bwcsh-1 Sharps Container, Bradford Wright Companies, Inc. (2014) Summary page 5.

## Indications for use
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.

Source page: https://510kreport.com/device/K182235
Methodology: https://510kreport.com/methodology