# K982029: Sharps Collection Container - Saf-T-Shell

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Mfg., Inc.
- Decided: Apr 6, 1999 after 301 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) Baxter: named in the summary without a submission number
- (no number) Becton Dickinson: named in the summary without a submission number
- (no number) Pro-Tec: named in the summary without a submission number
- (no number) Sage Products: named in the summary without a submission number
- (no number) Devon Industries: named in the summary without a submission number

## Indications for use
The American Medical Manufacturing, Inc, Sharps Collection Container ig to be used for collection and disposal of medical sharps in hospitals and doctors” offices.

Source page: https://510kreport.com/device/K982029
Methodology: https://510kreport.com/methodology