# K911037: Safety Needle Sheath, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: May 3, 1991 after 63 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.
5 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012736: Monoject Safety Needle (2001), 2 descendants of its own
- K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own
- K082908: Novaguard, Model 3611001 (2009), 0 descendants of its own
- K073188: Hypodermic Needle-Pro Edge Safety Device (2008), 0 descendants of its own
- K013006: Ovus Capless Safety Needle (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K911037
Methodology: https://510kreport.com/methodology