# K965248: Bemis Two Gallon Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Bemis Mfg. Co.
- Decided: Feb 14, 1997 after 72 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 Sharps Container: named in the summary without a submission number

## Recalls of this device
- Feb 25, 2004 · Not classified · Z-0789-04: The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the d

## Indications for use
The Bemis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies.

Source page: https://510kreport.com/device/K965248
Methodology: https://510kreport.com/methodology