# K013427: Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips M3000A/M3046A

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Nov 29, 2001 after 44 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 K971910 (1998). 2 ancestors in all.
407 later devices descend from it; 2 cite it directly.
0 of 410 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 1.

## Most influential descendants
- K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology (2002), 406 descendants of its own
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr (2003), 404 descendants of its own
- K031481: The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 (2003), 376 descendants of its own
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. (2003), 375 descendants of its own
- K040259: Masimo Set Intellivue Pulse Oximeter Module (2004), 312 descendants of its own

## Indications for use
Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.

Source page: https://510kreport.com/device/K013427
Methodology: https://510kreport.com/methodology