# K012226: Monitoring System,Model Argus PB-1000

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Apr 8, 2002 after 266 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 K970879 (1997). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970879: Cardiovit CS-200, Schiller America, Inc. (1997) Summary page 1.

## Most influential descendants
- K053207: Argus, Model LCM (2006), 5 descendants of its own
- K101619: Welch Allyn 1500 Patient Monitor (2010), 4 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K123556: Mortara Surveyor Patient Monitor (2013), 2 descendants of its own

## Indications for use
The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as: ECG: Heartrate, Asystolic Time, Respiration Rate invasive Blood Pressure: systolic, distolic and mean pressure Temperature: temperature and AT Non Invasive Blood Pressure: systolic, distolic and mean pressure CO,, etCO, and COsins SpOa: SpO; and pulse rate on humans and for the evaluation of Reéting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments. The system comprises the Parameter Box PB-1000 and the Visualisation Unit ARGUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

Source page: https://510kreport.com/device/K012226
Methodology: https://510kreport.com/methodology