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Elcam Disposable Integrated Pressure Transducer (Dipt)

by Elcam Medical ACAL 510(k)

Active United States

510(k) K120624

Overview

The Elcam Disposable Integrated Pressure Transducer (Dipt) is a transducer, blood-pressure, extravascular device intended for direct measurement and monitoring of blood pressure. It is a disposable, fully integrated pressure transducer designed for single use in critical care settings.

The device is supplied as a sterile, single-use transducer and is indicated for direct arterial blood pressure monitoring. It has received FDA 510(k) clearance under K120624 and is classified as a Class II medical device with product code DRS.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120624 Date8 Jun 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Elcam Disposable Integrated Pressure Transducer (Dipt) intended for?

    The Elcam Disposable Integrated Pressure Transducer (Dipt) is intended for direct measurement and monitoring of blood pressure, specifically for direct arterial blood pressure monitoring in critical care settings, as stated in its description and indications for use.

  • How is the Elcam Disposable Integrated Pressure Transducer (Dipt) supplied and is it reusable?

    The device is supplied as a sterile, single-use transducer designed for one-time use only, meaning it is not intended for reuse and must be discarded after each patient procedure to maintain sterility and prevent cross-contamination.

  • What regulatory pathway was used for the Elcam Disposable Integrated Pressure Transducer (Dipt) and what is its classification?

    The device received FDA 510(k) clearance under submission number K120624 and is classified as a Class II medical device with product code DRS, indicating it was found substantially equivalent to a legally marketed predicate device.