# K012461: Siemens Infinity Mib II Duo Protocol Converter

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 17, 2001 after 16 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 3 generations back to K923682 (1992). 6 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010640: Siemens Medical Information Bus (Mib II) Protocol Converter, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.
- K970368: SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K973222: SC9000/SC9015 Medical Information Bus (Mib) Protocol Converter, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K991661: Siemens Medical Information Bus (Mib) Protocol Converter, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K003248: Siemens Medical Information Bus (Mib) Protocol Converter, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.

## Most influential descendants
- K020277: Siemens Medical Infromation Bus (Mib II) Protocol Converter (2002), 39 descendants of its own
- K022766: Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter (2002), 38 descendants of its own
- K033807: Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter (2004), 37 descendants of its own
- K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL (2005), 36 descendants of its own
- K051658: Infinity Alpha (2005), 32 descendants of its own

## Indications for use
Siemens INFINITY MIB Il Duo Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 9000-+SC 7000 / SC 8000 / SC 9000XL) for the display of data. MIB connectivity to third party medical devices such as: Siemens SV 300 ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita Il ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Draeger Narkomed [ Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc.: OSI - Optical CAM VIA Medical: VIA V-ABG! Blood Gas Chemistry Monitor *Aspect A-2000 BIS Monitor *The SC 9000 does not support communication with the Aspect BIS Monitor MRI Compatibility Statement: The INFINITY MIB Il Duo Protocol Converter is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K012461
Methodology: https://510kreport.com/methodology