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Continuous Cardiac Output Monitoring System

by Cardio Metrics, Inc.

510(k) K870150

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870150 Date7 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JOP
Device Class
Class II
Regulation
21 CFR Part 870.2880
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

A continuous cardiac output monitoring system is a device used for the real-time measurement of cardiac output. It is classified as a transducer, ultrasonic device under FDA regulation number 870.2880 and product code JOP.

The system received FDA 510(k) clearance (K870150) on August 7, 1987, following a traditional review process. It is manufactured by Cardio Metrics, Inc. and is intended for cardiovascular monitoring applications.

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See all devices from Cardio Metrics, Inc. →

Questions

AI-generated answers, 6 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 continuous cardiac output monitoring system used for?

    The continuous cardiac output monitoring system is used for the real-time measurement of cardiac output, providing continuous cardiovascular monitoring during clinical procedures.

  • How is the continuous cardiac output monitoring system supplied and is it sterile?

    The device data does not specify supply format, sterility, or single-use/reuse status; these details are not included in the provided authorization or specifications.

  • What regulatory pathway was used for the continuous cardiac output monitoring system?

    The system received FDA 510(k) clearance (K870150) on August 7, 1987, following a traditional review process, and was found substantially equivalent to a predicate device.