# K946289: Devons Point Lok Needle Protection Device

- Pathway: 510(k) (Traditional)
- Applicant: Devon Industries, Inc.
- Decided: Jul 10, 1995 after 195 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.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K041153: Sharpsaway II Locking Disposable Cup (2004), 2 descendants of its own
- K070577: ON the GO Sharps (2007), 1 descendant of its own
- K083031: Portex Uniperc Percutaneous Dilation Tracheostomy Kit (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
- K043249: Atrion Needlevise Large-Bore Sharps Securing Device (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K946289
Methodology: https://510kreport.com/methodology