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Accucom 2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K874138

by Datascope Corp.

Identifiers

510(k) Number
K874138 FDA 510(k)
FDA Product Code
DPT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2120 FDA 510(k)
Regulation Number
870.2120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Accucom 2 is an extravascular blood-flow probe, classified under product code DPT. It is designed to measure blood flow velocity in real time, providing continuous-wave transesophageal Doppler monitoring for cardiac output assessment.

This device is intended for single-use applications in clinical settings, such as cardiac monitoring. Supplied sterile and regulated under FDA 510(k) clearance (K874138), it falls under Class II special controls for cardiovascular applications. No MRI safety information or reusable specifications are provided in the data.

Frequently asked questions

What clinical setting is the Accucom 2 probe intended for, and how does it function in that context?

The Accucom 2 is designed for cardiac monitoring in clinical settings, specifically for measuring blood flow velocity in real time via continuous-wave transesophageal Doppler. It provides continuous assessment of cardiac output, making it useful during procedures like cardiac catheterization, intraoperative monitoring, or critical care scenarios where precise hemodynamic data is required.

Is the Accucom 2 probe single-use or reusable, and what does that mean for its handling?

The Accucom 2 is intended for single-use only, meaning it should not be reused after a single clinical procedure. This design ensures sterility and safety, as it is supplied sterile from the manufacturer. After use, it must be discarded according to standard medical waste protocols.

How is the Accucom 2 probe regulated, and what does that mean for its use in hospitals?

The Accucom 2 is regulated under the FDA’s 510(k) clearance process (K874138) and classified as Class II under special controls for cardiovascular applications. This means it has undergone FDA review to demonstrate substantial equivalence to a previously cleared device, ensuring it meets safety and performance standards for extravascular blood-flow measurement. Hospitals can use it with confidence in its compliance with U.S. regulatory requirements.

Are there different sizes or models of the Accucom 2 probe, and how should it be stored?

The provided data does not specify distinct sizes or models of the Accucom 2 probe beyond its core function as an extravascular blood-flow probe. For storage, since it is sterile and single-use, it should be kept in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow manufacturer instructions for unpacking and preparation.

What medical specialties or procedures would most commonly utilize the Accucom 2 probe?

The Accucom 2 is primarily used in cardiovascular specialties, including cardiac surgery, anesthesiology, and critical care units. Its real-time Doppler monitoring capability is particularly valuable during intraoperative cardiac assessments, cardiac catheterization, or hemodynamic monitoring in patients with complex cardiac conditions, where precise blood flow data is critical for decision-making.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACCUCOM 2 (K874138) - FDA 510 (k), ACCUCOM 2 510 (k) K874138 - FDA.report, Datascope Corp. FDA Filings - FDA.report, Reliability of a New Generation Transesophageal Doppler Device for ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K874138 24 fields · synced Sep 19, 2026