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FDA 510(k)

TruPress

K-Number: K254074 · 2026-09-10

ApplicantProcerus Enterprises
Decision Date2026-09-10
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TruPress is the device name listed in this FDA 510(k) record. The listed applicant is Procerus Enterprises. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K254074. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruPress?

TruPress is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Procerus Enterprises. The 510(k) number is K254074.

When did TruPress receive FDA 510(k) clearance?

TruPress received FDA 510(k) clearance on 2026-09-10, under 510(k) number K254074.

Who is the listed applicant for TruPress?

The FDA 510(k) record lists Procerus Enterprises as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruPress?

The FDA product code for TruPress is DRS.

Related Devices (Code: DRS)

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.

K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products CorporationK152472Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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