# K973911: 2 Gallon Alternate Care Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Sage Products, Inc.
- Decided: Oct 29, 1997 after 15 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) 2 Gallon Sharps Container with Hinged Lid and Rotor #8535: named in the summary without a submission number
- (no number) 5 Quart Sharp Star #8508: named in the summary without a submission number
- (no number) 2 Quart Sharps Disposal Container #1522: named in the summary without a submission number

## Indications for use
The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including; but not limited to, hypodermic needles, syringes, lancets, [V Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and non-clinical settings.

Source page: https://510kreport.com/device/K973911
Methodology: https://510kreport.com/methodology