# K201523: Sharps container

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.
- Decided: Nov 12, 2020 after 157 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 K132767 (2014). 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)
- K190240: Tiger Sharps Containers, International Marketing Specialists, Inc. (2019) Summary page 8.

## Indications for use
Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.

Source page: https://510kreport.com/device/K201523
Methodology: https://510kreport.com/methodology