# K101619: Welch Allyn 1500 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Nov 12, 2010 after 156 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: 10 generations back to K962603 (1997). 77 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 82 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053207: Argus, Model LCM, Schiller AG (2006) Summary page 1.
- K063814: BP-200 Plus, Schiller AG (2007) Summary page 1.
- K051352: Oximax NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2005) Summary page 2.
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX, Datascope Corp. (2002) Summary page 5.
- K072295: Capnostream 20 with A2 Adaptive Averaging Software, Oridion Capnography, Inc. (2007) Summary page 5.

## Most influential descendants
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own
- K201746: Tempus Pro Patient Monitor (2020), 0 descendants of its own

## Indications for use
The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates; children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring. Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery. The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure (NIBP), invasive blood pressure (11BP), temperature and respiration of a patient. >The device is intended to be used by qualified doctors or trained medical personnel. >The device is not suitable for transport. >There is no danger for patients with pacemaker. >The device is intended for the monitoring of one patient at a time. > The device is not designed for sterile use nor is it designed for outdoor use. - Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases. > The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation. > This product is not designed for direct cardiac application. > The arrhythmia module is not intended for use with neonatal patients. > The ST-analysis module is not intended for use with neonatal patients.

Source page: https://510kreport.com/device/K101619
Methodology: https://510kreport.com/methodology