Decision Date2026-03-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PRESSONE™ is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2026-03-24 under 510(k) 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. The listed applicant is Nipro Medical Corporation. The 510(k) number is K253047.
When did PRESSONE™ receive FDA 510(k) clearance?
PRESSONE™ received FDA 510(k) clearance on 2026-03-24, under 510(k) number K253047.
Who is the listed applicant for PRESSONE™?
The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PRESSONE™?
The FDA product code for PRESSONE™ is FMI.
Other records listing Nipro Medical Corporation as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.