# K052707: M3046B Compact Portable Patient Monitors

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Oct 20, 2005 after 21 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: 5 generations back to K941811 (1994). 22 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971910: Multi-Parameter Module (M3000A)/Display Unit (M3046A), Hewlett-Packard GmbH (1998) Summary page 1.
- K981576: Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A, Hewlett-Packard GmbH (1998) Summary page 2.
- K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T, Hewlett-Packard GmbH (1999) Summary page 2.
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P, Hewlett-Packard GmbH (1999) Summary page 2.
- K992273: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,Rel B, Hewlett-Packard GmbH (2000) Summary page 2.
- K993383: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B, Hewlett-Packard GmbH (2000) Summary page 2.
- K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Technologies, GmbH (2000) Summary page 2.
- K001057: Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact Portable Patient Monitor, Agilent Technologies, Inc. (2000) Summary page 2.
- K001333: Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni, Agilent Technologies Deutschland GmbH (2000) Summary page 2.
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 (2008), 18 descendants of its own
- K090483: Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient Monitors (2009), 14 descendants of its own
- K082280: Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor (2008), 11 descendants of its own
- K101067: Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 (2010), 7 descendants of its own
- K120132: Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor (2012), 6 descendants of its own

## Recalls of this device
- Apr 30, 2008 · Not classified · Z-1911-2008: Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval n

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.

Source page: https://510kreport.com/device/K052707
Methodology: https://510kreport.com/methodology