Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246

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

510(k) Number

K012451 ↗

FDA Product Code

DRT

Models / Variants

Propaq Encore Models 202, 204, 206

Propaq Cs Models 242, 244, 246

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Acuity Central Monitoring System

  Class II

  FDA 510(k) K022453 Active Cleared 21 Aug 2002

• Modification to Vsm- Vital Signs Monitor, (Vsm 300 )

  Class II

  FDA 510(k) K063419 Active Cleared 4 Dec 2006

• Vsm - Vital Signs Monitor, Model 53000 Series

  Class II

  FDA 510(k) K031740 Active Cleared 26 Aug 2003

• Micropaq, Models 402, 404

  Class II

  FDA 510(k) K021681 Active Cleared 23 Jul 2002

• Link to Acuity Clinician Notifier

  Class II

  FDA 510(k) K070204 Active Cleared 23 Mar 2007

• Vital Signs Monitor, Propaq Lt

  Class II

  FDA 510(k) K033378 Active Cleared 1 Mar 2004

• What clinical settings are the Propaq Encore and Propaq CS monitors designed for?

  These monitors are intended for use in clinical environments where continuous cardiac monitoring is essential, such as hospitals, intensive care units (ICUs), and emergency departments. They are specifically designed to assess cardiac function and patient stability by providing real-time ECG waveforms, heart rate, non-invasive blood pressure (NIBP), and invasive blood pressure (BP) measurements.

• Are the Propaq Encore and Propaq CS monitors reusable or single-use?

  These devices are supplied as reusable, non-sterile monitors. They are intended for repeated use in clinical settings, provided they are properly cleaned, maintained, and stored according to the manufacturer’s guidelines to ensure accurate and reliable performance.

• Do these monitors support MRI compatibility?

  Yes, the Propaq Encore and Propaq CS models are cleared for MRI safety under specific conditions. This means they can be used in MRI environments where appropriate safety protocols are followed, reducing the risk of interference or harm during imaging procedures.

• What models are included in the Propaq Encore and Propaq CS series?

  The Propaq Encore series includes models 202, 204, and 206, while the Propaq CS series includes models 242, 244, and 246. Each model is designed to provide high-resolution waveform annotation and compatibility with central monitoring systems for remote control and data transmission.

• How should these monitors be stored and maintained?

  Storage and maintenance of the Propaq Encore and Propaq CS monitors follow manufacturer guidelines to ensure optimal performance. This includes regular cleaning, calibration, and inspection to prevent malfunctions. Proper storage conditions, such as avoiding extreme temperatures or humidity, are also critical to maintaining device integrity and accuracy.