# K980179: Sharps Plus 5 Gallon Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Rotonics Mfg., Inc.
- Decided: Apr 13, 1998 after 83 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- 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.
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) BioSystem BioBox reusable sharps container: named in the summary without a submission number

## Indications for use
The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps. Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities. Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.

Source page: https://510kreport.com/device/K980179
Methodology: https://510kreport.com/methodology