K253047
- 510(k) number
- K253047
- Device name
- PRESSONE
- Applicant
- Nipro Medical Corporation FL · US
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2026-03-24
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K253047.pdf
Official FDA record: K253047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.