Omni-Central Station Monitor

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

510(k) Number

K936051 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Omega 5000

  Class II

  FDA 510(k) K833978 Active Cleared 9 Mar 1984

• Omni-Trak (Patient Monitor)

  Class II

  FDA 510(k) K890817 Active Cleared 10 Aug 1989

• Invivo Pulse Oximeter, Model 4500

  Class II

  FDA 510(k) K864730 Active Cleared 6 May 1987

• Millennia 3500 Series Monitor with Anthesthetic Agent

  Class II

  FDA 510(k) K974581 Active Cleared 28 Oct 1998

• Integrated Patient Monitoring System

  Class II

  FDA 510(k) K041918 Active Cleared 15 Oct 2004

• Centurion 2000 Central Station Arrhythmia Patient Monitoring System

  Class II

  FDA 510(k) K002604 Active Cleared 7 Feb 2002

See all devices from Invivo Research, Inc. →

• What is the Omni-Central Station Monitor used for?

  The Omni-Central Station Monitor is designed as a cardiotachometer and rate alarm to continuously track and display heart rate data from multiple patients simultaneously. It functions as a centralized monitoring system in clinical settings like intensive care units (ICUs) or cardiac care units, allowing healthcare providers to aggregate and oversee heart rate signals from connected patient monitors in real time. This helps in detecting arrhythmias and ensuring timely clinical intervention.

• Is the Omni-Central Station Monitor reusable or single-use?

  The Omni-Central Station Monitor is reusable and intended for use in healthcare facilities as a non-sterile medical device. Since it is designed for repeated use across multiple patients, proper calibration, maintenance, and cleaning protocols must be followed to ensure reliability and patient safety. Sterility is not required for this device.

• What regulatory approval does the Omni-Central Station Monitor hold?

  The Omni-Central Station Monitor holds FDA 510(k) clearance under the classification of Device Class II (DRT). It was determined to be substantially equivalent to a predicate device through a traditional review process by the FDA’s Cardiovascular (CV) Advisory Committee. The clearance number is K936051, and it adheres to regulatory standards for cardiac monitoring devices.

• How should the Omni-Central Station Monitor be stored and handled?

  The Omni-Central Station Monitor must be stored and handled according to standard medical device protocols to maintain its functionality and ensure patient safety. Since it is a reusable device, it should be cleaned, calibrated, and inspected before each use. Additionally, if used in proximity to MRI equipment, adherence to MRI safety guidelines is required to prevent interference or damage to the device.

• Can the Omni-Central Station Monitor be used with other patient monitors?

  Yes, the Omni-Central Station Monitor is part of a central station monitoring system specifically designed to aggregate signals from connected patient monitors. It consolidates heart rate data from multiple sources, enabling centralized oversight of arrhythmias and other cardiac parameters in high-dependency areas like ICUs or cardiac care units.