# K944355: Nipro Branded Disposable Syringes, Needles

- Pathway: 510(k) (Traditional)
- Applicant: Nissho Corp.
- Decided: Dec 7, 1994 after 91 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 6 cite it directly.
0 of 44 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
- K030683: Nipro Disposable Syringes (2003), 23 descendants of its own
- K052474: Nipro Hypodermic Needle (2005), 13 descendants of its own
- K102584: Imc Hypodermic Needle (2011), 12 descendants of its own
- K051574: Nipro Disposable Syringe with or Without Needle (2005), 10 descendants of its own
- K061194: Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558 (2006), 9 descendants of its own

Source page: https://510kreport.com/device/K944355
Methodology: https://510kreport.com/methodology