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IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter

by Shanghai Draeger Medical Instrument Co., Ltd.

510(k) K251669

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251669 Date30 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Intravascular Pressure Transducer Adapter Cable (DSA Product Code), designed to connect intravascular pressure transducers to monitoring systems. It facilitates accurate transmission of pressure signals from catheters or monitoring lines to external devices, ensuring reliable hemodynamic measurements in clinical settings.

The IBP Transducer Adapter Cable is supplied in multiple configurations, including lengths of 0.3m and 2m, with compatibility for various manufacturer interfaces (e.g., Draeger 7-pin/10-pin, Argon/BD/Ohmeda, Abbott/Medex, Smiths/TranStar, Baxter/Edwards). It is intended for single-use and must be handled with sterile technique in controlled environments such as operating rooms or intensive care units. The device holds FDA 510(k) clearance (K251669) under the Traditional pathway, classified as Substantially Equivalent by the Cardiovascular Advisory Committee.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios or settings would this device be used in, and why is it important there?

    This IBP transducer adapter cable is designed for use in critical care environments like operating rooms, intensive care units, and cardiac catheterization labs, where precise hemodynamic monitoring is essential. It connects intravascular pressure transducers to monitoring systems, ensuring accurate transmission of pressure signals from catheters or monitoring lines. This reliability is crucial for real-time assessment of blood pressure, cardiac output, and other vital measurements during high-risk procedures or patient stabilization.

  • Are these cables reusable, or are they meant for single-use only? How does that affect handling?

    These cables are explicitly intended for single-use only, as specified in the device description. This means they must be handled with sterile technique in controlled environments like operating rooms or ICUs to prevent contamination. After use, they should be discarded according to facility protocols to maintain patient safety and device integrity.

  • What lengths and manufacturer-specific connectors are available, and how do I choose the right one?

    The cables come in two standard lengths: 0.3 meters and 2 meters. They are also compatible with multiple manufacturer interfaces, including Draeger (7-pin and 10-pin), Argon/BD/Ohmeda, Abbott/Medex/Smiths/TranStar, and Baxter/Edwards. To select the correct one, verify the connector type on your monitoring system and the length required for your setup—shorter lengths (0.3m) may be preferred for compact spaces, while longer lengths (2m) offer greater flexibility in patient positioning.

  • How is the regulatory status of this device determined, and what does that mean for purchasing or use?

    This device holds FDA 510(k) clearance (K251669) under the Traditional pathway, classified as *Substantially Equivalent* by the Cardiovascular Advisory Committee. This means it has been reviewed and deemed comparable to a legally marketed predicate device, ensuring it meets U.S. safety and performance standards. For purchasing or use, this clearance confirms the device’s compliance with regulatory requirements, but it does not imply any specific clinical indication—only that it functions as described for connecting pressure transducers to monitoring systems.

  • What storage conditions should be followed to maintain the cable’s integrity before use?

    While the device description doesn’t specify exact storage conditions, single-use medical devices like this typically require protection from physical damage, contamination, and extreme temperatures. Store the cables in their original packaging, away from direct sunlight or moisture, and ensure they remain dry and uncontaminated until use. Check for any manufacturer-specific instructions on the packaging, as improper storage could compromise sterility or functionality.