# K904198: Safety Needle Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: Dec 19, 1990 after 98 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.
86 later devices descend from it; 2 cite it directly.
1 of 87 devices in its family (counting itself) has 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
- K923127: Needle-Pro Cartridge (1993), 84 descendants of its own
- K031453: Terumo Surguard 2 Safety Needle (2003), 74 descendants of its own
- K040531: Terumo SURGUARD2 Safety Needle (2004), 67 descendants of its own
- K051865: Terumo Surguard 2 Safety Needle or Similar (2005), 65 descendants of its own
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle (2012), 60 descendants of its own

Source page: https://510kreport.com/device/K904198
Methodology: https://510kreport.com/methodology