# K931664: Sharps Disposable Containers

- Pathway: 510(k) (Traditional)
- Applicant: Bemis Mfg. Co.
- Decided: May 23, 1994 after 413 days
- Product code: MMK (Container, Sharps)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G (2002), 3 descendants of its own
- K083511: Enviro Sharp Solutions 3 (2009), 1 descendant of its own
- K131087: Sharpstank Reusable Sharps Container (2013), 0 descendants of its own
- K081821: D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) (2008), 0 descendants of its own

## Recalls of this device
- Aug 23, 2006 · Not classified · Z-0170-2007: The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.

Source page: https://510kreport.com/device/K931664
Methodology: https://510kreport.com/methodology