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Innocor

by Innovision A/S

510(k) K051907

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 NumberK051907 Date2 Mar 2006ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Innocor is a non-invasive cardiac output monitor (Computer, Diagnostic, Programmable; Product Code DQK), designed to measure cardiac output using gas exchange principles. It employs a validated method to assess cardiac function without invasive procedures, providing real-time data for clinical and research applications. Suitable for both hospital and research settings, it supports non-invasive evaluation of hemodynamic parameters. The device falls under Class II regulatory classification with special controls in place.

Innocor is supplied as a reusable medical instrument, intended for use in controlled clinical environments. It requires calibration and maintenance as specified in the manufacturer’s instructions, though sterility is not a requirement for its operation. The device is MRI-unsafe and must be used in compliance with local regulatory standards, including the FDA’s 510(k) clearance (K051907) granted in 2006. Storage and handling follow manufacturer guidelines to ensure accurate performance and longevity.

Other devices from Innovision A/S

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Innocor used for?

    The Innocor is a non-invasive cardiac output monitor designed to measure cardiac function using gas exchange principles. It provides real-time hemodynamic data without requiring invasive procedures, making it suitable for clinical and research settings where continuous assessment of cardiac performance is needed.

  • Is the Innocor a single-use or reusable device?

    The Innocor is a reusable medical instrument. It is intended for use in controlled clinical environments and requires calibration and maintenance as outlined in the manufacturer’s instructions to ensure accurate performance over repeated uses.

  • Does the Innocor require sterilization before each use?

    No, sterility is not a requirement for the Innocor. It is designed for reusable use in controlled environments, and proper cleaning and maintenance procedures—per the manufacturer’s guidelines—are sufficient to prepare it for subsequent uses.

  • What regulatory approval does the Innocor have?

    The Innocor holds FDA 510(k) clearance (K051907) under the traditional review pathway, granted in 2006. It is classified as a Class II device with special controls in place, ensuring compliance with U.S. regulatory standards for non-invasive cardiac output monitoring.

  • Can the Innocor be used in an MRI environment?

    No, the Innocor is not MRI-safe. It must be used in compliance with local regulatory standards, and care must be taken to avoid exposure to MRI environments to prevent interference or safety risks.