# K984194: HP M2376A Device Link System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Apr 30, 1999 after 158 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K923682 (1992). 1 ancestor in all.
79 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923682: Model M1032A Vuelink Interface Plug-in Module, Hewlett-Packard Co. (1992) Summary page 1.

## Most influential descendants
- K992636: HP Carevue 9000 Clinical Information System, Model M2331A (1999), 78 descendants of its own
- K100272: Intellivue Clinical Information Portfolio (2010), 46 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own

## Indications for use
The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below: 1) IMED 1310 (PC-1) channel IV Pump 2) In-line Diagnostic HR Crit-Line Monitor 3) Newport Wave Ventilator

Source page: https://510kreport.com/device/K984194
Methodology: https://510kreport.com/methodology