Model 78553A Pressure Plug-In Module

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822878 ↗

FDA Product Code

DSK

Device Class

Class II

Regulation

21 CFR Part 870.1110

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary use case for the Model 78553A Pressure Plug-In Module in clinical settings?

  The Model 78553A is designed as a reusable peripheral component for blood-pressure measurement systems. It interfaces with monitoring devices to process and display arterial pressure data, enabling cardiovascular assessments in hospital or clinical environments. This allows clinicians to continuously track blood pressure trends for better patient monitoring.

• Is the Model 78553A Pressure Plug-In Module intended for single-use or reusable applications?

  The regulatory records for the Model 78553A explicitly state it is intended for reuse within blood-pressure monitoring systems. No information regarding single-use or sterility is provided, so it should be handled according to manufacturer guidelines for reusable medical devices.

• What regulatory pathway was followed for FDA clearance of this device?

  The Model 78553A was cleared through the traditional 510(k) pathway under FDA clearance number K822878. It was classified as a Class II device under regulation 870.1110 and submitted to the Cardiovascular Advisory Committee (CV) in 1982. The decision was based on substantial equivalence to a predicate device.

• Are there any known compatibility or integration requirements for this module?

  The Model 78553A is specifically designed as a plug-in module for blood-pressure measurement systems, meaning it requires compatibility with the host device it connects to. While the exact integration details are not specified in the records, it is intended for use with monitoring systems that support its function as a pressure-processing component. Always verify compatibility with your existing equipment.