PRESSONE
K-Number: K253047 · 2026-03-24
ApplicantNipro Medical Corporation
Decision Date2026-03-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PRESSONE is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2026-03-24 under approval number K253047. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PRESSONE?
PRESSONE is a medical device that received FDA 510(k) clearance on 2026-03-24. It is manufactured by Nipro Medical Corporation. The 510(k) number is K253047.
When was PRESSONE approved by the FDA?
PRESSONE received FDA 510(k) clearance on 2026-03-24, under approval number K253047.
What company makes PRESSONE?
PRESSONE is manufactured by Nipro Medical Corporation.
What is the FDA product code for PRESSONE?
The FDA product code for PRESSONE is FMI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.