# K253047: Pressone™

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Mar 24, 2026 after 183 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: 3 generations back to K931367 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 5.

## Indications for use
PRESSONE™ is indicated for use with syringes for general purpose fluid injection/withdrawal.

Source page: https://510kreport.com/device/K253047
Methodology: https://510kreport.com/methodology