# K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 18, 2005 after 66 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
Longest line of descent: 7 generations back to K923682 (1992). 33 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033694: Infinity Modular Monitors VF4 Modifications, Draeger Medical Systems, Inc. (2004) Summary page 1.
- K033807: Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter, Draeger Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K051658: Infinity Alpha (2005), 32 descendants of its own
- K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications (2006), 27 descendants of its own
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL (2007), 26 descendants of its own
- K061379: Infinity Telesmart Telemetry System (2007), 26 descendants of its own
- K130711: Infinity Centralstation with Infinity M300 (2013), 25 descendants of its own

## Indications for use
The INFINITY Modular monitors are capable of monitoring: * Heart rate * Respiration rate * Invasive pressure * Non-invasive pressure * Arrhythmia * Temperature * Cardiac output * Arterial oxygen saturation * Pulse rate * Apnea * ST Segment Analysis * 12-Lead ST Segment Analysis * tcpO2/tcpCO2 * EEG signals * FiO2

Source page: https://510kreport.com/device/K043439
Methodology: https://510kreport.com/methodology