Escort II+ 400 Series (Escort Prism) Monitor

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

510(k) Number

K992411 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Escort-Link Central Station Monitor Model 20500

  Class II

  FDA 510(k) K982104 Active Cleared 25 Nov 1998

• Escort Link Central Station Monitor

  Class II

  FDA 510(k) K970012 Active Cleared 26 Jun 1997

• Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412, 20413, 20414

  Class II

  FDA 510(k) K014294 Active Cleared 25 Jan 2002

• Escort - Portable Patient Monitor

  Class II

  FDA 510(k) K881986 Active Cleared 12 Jul 1988

• Escort 300A Series Defibrillator/Pacer Option

  Class II

  FDA 510(k) K914458 Active Cleared 9 Dec 1991

• Escort 100/300 Series B (Escort II) Patient Monitor

  Class II

  FDA 510(k) K992413 Active Cleared 19 Aug 1999

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• What is the Escort Prism 400 Series Cardiac Monitor used for?

  The Escort Prism 400 Series Cardiac Monitor is designed to continuously assess and display vital cardiac parameters, including heart rate and rhythm. It supports clinical decision-making in hospital settings by providing real-time monitoring for adult, pediatric, and neonatal patients. This ensures timely detection of cardiac abnormalities, which is critical in acute care environments where rapid response is essential.

• How is the Escort Prism 400 Series supplied and maintained?

  The Escort Prism 400 Series is supplied as a reusable device. To ensure sterility and functionality between uses, it requires proper cleaning, disinfection, and maintenance procedures. This includes adherence to manufacturer guidelines for reprocessing to prevent contamination and maintain performance standards, particularly important in clinical environments where hygiene is paramount.

• Is the Escort Prism 400 Series single-use or reusable?

  The Escort Prism 400 Series is a reusable device. Unlike single-use monitors, it is designed for repeated use in clinical settings, provided it undergoes thorough cleaning, disinfection, and maintenance between patient encounters. This design supports cost efficiency and sustainability while ensuring reliability in continuous cardiac monitoring.

• What model variants are available for the Escort Prism 400 Series?

  The Escort Prism 400 Series is available in multiple model variants, including but not limited to the 20400, 20401, and 20403. These variants may differ in specific features or configurations, allowing healthcare providers to select the model best suited for their patient population or clinical workflow. The manufacturer’s documentation should be consulted to determine the exact differences between models.

• How should the Escort Prism 400 Series be stored?

  The Escort Prism 400 Series should be stored in a clean, dry environment protected from extreme temperatures, humidity, and direct sunlight. Proper storage conditions are essential to preserve the device’s functionality and ensure its readiness for use when needed. Additionally, storage should comply with manufacturer recommendations to maintain calibration and performance integrity over time.