Sabratek Patient Home Management System

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

510(k) Number

K980619 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K983355 Active Cleared 12 Mar 1999

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• Sabratek 6060 Homerun Volumetric Infusion Pump

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  FDA 510(k) K941984 Active Cleared 19 Jul 1994

• Sabratek 3030 Infusion Pump

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• Sabratek 4040 Infusion Pump

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• 3030 Infusion Pump

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  FDA 510(k) K955258 Active Cleared 3 Jun 1996

• What is the SABRATEK Patient Home Management System used for?

  The SABRATEK Patient Home Management System is a physiological patient monitor with arrhythmia detection or alarms, designed specifically for monitoring patients requiring cardiac monitoring capabilities in a home setting. It falls under the cardiovascular medical specialty.

• How is the SABRATEK Patient Home Management System supplied?

  The system is supplied as a Class II medical device with FDA 510K clearance (K980619) and is regulated under product code MHX. It is manufactured by Sabratek Corp. and includes various model numbers and registration numbers as specified in the regulatory documentation.

• What is the regulatory status of the SABRATEK Patient Home Management System?

  The SABRATEK Patient Home Management System has FDA 510K clearance (K980619) and is classified as a Class II medical device under product code MHX. It was reviewed by the Cardiovascular advisory committee and received a decision code of SESE (Substantially Equivalent) on 1998-08-20.

• Is the SABRATEK Patient Home Management system reusable or single-use?

  The device data does not specify whether the SABRATEK Patient Home Management System is designed for single-use or multiple reuse. This information would be detailed in the product's instructions for use, which should be consulted for proper handling and disposal procedures.