# K980619: Sabratek Patient Home Management System

- Pathway: 510(k) (Traditional)
- Applicant: Sabratek Corp.
- Decided: Aug 20, 1998 after 183 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871720 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options, Protocol Systems, Inc. (1996) Summary page 4.
- K960851: Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor, Pro-Tech Services, Inc. (1996) Summary page 4.
- K911529: Bunny Electrode/Stealth Electrode Pre Wired Eeg, Lead-Lok, Inc. (1992) Summary page 4.
- K871720: Modified Model UA-731 Digital Sphygmomanometer, A&D Engineering, Inc. (1987) Summary page 4.
- (no number) AND Medical UC-300: named in the summary without a submission number
- (no number) MA-200: named in the summary without a submission number
- (no number) Nonin OEM II: named in the summary without a submission number

## Most influential descendants
- K993643: Nexsystem Ambulatory Patient Monitor Model Nex 100 (1999), 0 descendants of its own

## Indications for use
The Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system intended for use predominately in alternate care settings. It consists of an ambulatory, patient-worn monitor (the APM-2000), a communications module located in the patient care setting (the Virtual Hospital Room Communicator), and personal-computer-based data display and storage software (Remote Device Access Software, RDAS) located at the healthcare provider facility. The APM-2000 is a patient-worn physiological data recorder which stores ECG waveform data, temperature, respiration rate, arterial blood oxygen saturation, and pulse from non-invasive sensors.

Source page: https://510kreport.com/device/K980619
Methodology: https://510kreport.com/methodology