# K955514: Sharps Safe 1.5 & Sharps Safe 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Dura-Vac Products
- Decided: Aug 1, 1996 after 241 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
Longest line of descent: 1 generation back to K943892 (1994). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K943892: Point of Use Sharps a Gator, Devon Industries, Inc. (1994) Summary page 1.

## Most influential descendants
- K990936: The Vault (1999), 1 descendant of its own
- K091690: Sharp Chute (2009), 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

## Indications for use
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.

Source page: https://510kreport.com/device/K955514
Methodology: https://510kreport.com/methodology