# K943892: Point of Use Sharps a Gator

- Pathway: 510(k) (Traditional)
- Applicant: Devon Industries, Inc.
- Decided: Dec 2, 1994 after 115 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.
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
- K955514: Sharps Safe 1.5 & Sharps Safe 2.0 (1996), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K943892
Methodology: https://510kreport.com/methodology