# K990936: The Vault

- Pathway: 510(k) (Traditional)
- Applicant: Stik Stoppers, Inc.
- Decided: May 18, 1999 after 60 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
Longest line of descent: 2 generations back to K943892 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955514: Sharps Safe 1.5 & Sharps Safe 2.0, Dura-Vac Products (1996) Summary page 2.
- K964387: Point of Use II Sharps-a-Gator, Graphic Controls Corp. (1997) Summary page 2.
- K972279: Sharps Shuttle, Sage Products, Inc. (1997) Summary page 2.

## Most influential descendants
- K091690: Sharp Chute (2009), 0 descendants of its own

## Indications for use
The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT’s in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.

Source page: https://510kreport.com/device/K990936
Methodology: https://510kreport.com/methodology