# K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Apr 12, 2006 after 96 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K923682 (1992). 52 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL, Draeger Medical Systems, Inc. (2005) Summary page 1.
- K042904: Infinity Kappa XLT, Draeger Medical Systems, Inc. (2005) Summary page 1.
- K050974: Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol Converters, Draeger Medical Systems, Inc. (2005) Summary page 1.
- K053484: Infinity Gamma / Gammaxl, Infinity Vista, Draeger Medical Systems, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL (2007), 26 descendants of its own
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 descendants of its own
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own

## Recalls of this device
- Nov 17, 2006 · Not classified · Z-0301-2007: Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.

## Indications for use
The SClO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, N20, 02 and one of the anesthetic agents, Halothane, Isofiurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter. The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter CardiacOutput, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia. MRI Compatibility Statement: The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K060039
Methodology: https://510kreport.com/methodology