# K061590: Smdie Device Interfacing System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Health Services Corporat
- Decided: Jun 21, 2006 after 13 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
Longest line of descent: 4 generations back to K000635 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012094: Modification to Device Link System, Model M2376A, Agilent Technologies, Inc. (2001) Summary page 2.
- K021454: Unity Network ID, General Electric Medical Systems Information Techn (2002) Summary page 2.
- K032142: Datacaptor, Capsule Technologie (2003) Summary page 2.
- K980688: Integriti Patient Monitor, Alliance Instruments (1999) Summary page 2.
- K033283: Centra View Device Link System, Icu Datasystems, Inc. (2003) Summary page 2.

## Indications for use
The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.

Source page: https://510kreport.com/device/K061590
Methodology: https://510kreport.com/methodology