PRESSONE— 510(k) K253047
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K253047 for PRESSONE, Substantially Equivalent on 2026-03-24. Applicant: Nipro Medical Corporation. Device class: 2.
Summary
Nipro Medical's PRESSONE is filed under FMI, single-lumen hypodermic needles. The record doesn't give gauges, lengths or model numbers.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Nipro Medical filed from Miami, Florida. The decision came 183 calendar days after receipt (September 22, 2025 to March 24, 2026).
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Product code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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More clearances from Nipro Medical Corporation
view allAdverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.