# K012094: Modification to Device Link System, Model M2376A

- Pathway: 510(k) (Special)
- Applicant: Agilent Technologies, Inc.
- Decided: Jul 20, 2001 after 15 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K021454: Unity Network ID (2002), 1 descendant of its own
- K061590: Smdie Device Interfacing System (2006), 0 descendants of its own

## Indications for use
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Source page: https://510kreport.com/device/K012094
Methodology: https://510kreport.com/methodology