# K981576: Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard GmbH
- Decided: Jul 17, 1998 after 74 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
No predicates in its family tree.
472 later devices descend from it; 9 cite it directly.
0 of 473 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T (1999), 462 descendants of its own
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P (1999), 455 descendants of its own
- K993383: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B (2000), 451 descendants of its own
- K992273: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,Rel B (2000), 451 descendants of its own
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B (2001), 431 descendants of its own

## Indications for use
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient’s clinician deems it appropriate to use a device that: a) Can measure and display multiple physiological parameters' and waves' of one patient, and can generate alarms and printouts based on those measurements. b) Can be used on adult, pediatric, and neonatal patients as specified in the Technical Data Sheets. 1. List of supported measurements (a) ECG (b) Respiration (¢) Invasive blood pressure (d) Non-invasive blood pressure (¢) SpO,and Pleth (f) Temperature

Source page: https://510kreport.com/device/K981576
Methodology: https://510kreport.com/methodology