# K221056: Argus PB-3000

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Jul 6, 2023 after 451 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970879 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012226: Monitoring System,Model Argus PB-1000, Schiller AG (2002) Summary page 5.

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2672-2025: Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

## Indications for use
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient. Indicated for the following applications: ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient’s ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System). Respiration rate and apnea monitoring is indicated for pneumatic issues. IBP - Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient’s condition or response to therapy. It may also be used to aid in medical diagnosis. NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure. SpO2 - These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. This monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. CO2 - The CO2 measurement is used to detect trends in the level of inspired or expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. Respiration rate and apnea monitoring is indicated for pneumatic issues. Cardiac Output (CO) - Cardiac Output measurement is indicated for use in patients who require a non-continuous measurement of the stroke volume and l/min volume of the heart. Temperature - Temperature measurement is indicated in any patient that has a risk of high or low temperature.

Source page: https://510kreport.com/device/K221056
Methodology: https://510kreport.com/methodology