# K960963: Cord Wrap with Needle Resheather

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Medical Corp.
- Decided: May 6, 1996 after 56 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: 1 generation back to K883133 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883133: Hanger, Intravenous/I.V. Bag Hanger or Holder, Ferguson Medical (1988) Summary page 1.

Source page: https://510kreport.com/device/K960963
Methodology: https://510kreport.com/methodology