# K083129: Sharps Compliance Container

- Pathway: 510(k) (Traditional)
- Applicant: Sharps Compliance, Inc.
- Decided: Dec 15, 2008 after 54 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K097391: Sage 2 Gallon Alternate Care Sharps Container. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132792: Ecoship Disposable Sharps Container, Ecoship Disposable Sharps Container (2014), 0 descendants of its own

## Indications for use
The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.

Source page: https://510kreport.com/device/K083129
Methodology: https://510kreport.com/methodology