# K180983: Maxcon Two Gallon Chemotherapy Container

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Maxcon Medical Technology Co., Ltd.
- Decided: Jan 3, 2019 after 265 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: 1 generation back to K964858 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964858: Bemis Two Gallon Chemotherapy Container, Bemis Mfg. Co. (1997) Summary page 4.

## Indications for use
Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse’s stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.

Source page: https://510kreport.com/device/K180983
Methodology: https://510kreport.com/methodology