# K964858: Bemis Two Gallon Chemotherapy Container

- Pathway: 510(k) (Traditional)
- Applicant: Bemis Mfg. Co.
- Decided: Feb 11, 1997 after 69 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter Two Gallon Chemotherapy Container: named in the summary without a submission number

## Most influential descendants
- K180983: Maxcon Two Gallon Chemotherapy Container (2019), 0 descendants of its own

## Indications for use
The Bernis Twn Gallon Chemotherapy Container is a sharps disposal container. Itis intended for the safe disposal of needles, syringes, and other chemotherapy waste in arcas with controlled access which typically include nurse’s stations, oncology, pharmacies, and chemotherapy treatment rooms.

Source page: https://510kreport.com/device/K964858
Methodology: https://510kreport.com/methodology