# K152407: Infinity Delta, Infinity Delta XL, Infinity Kappa

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Sytems, Inc.
- Decided: Sep 23, 2015 after 29 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K923682 (1992). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL, Draeger Medical Systems, Inc. (2007) Summary page 7.

## Recalls of this device
- Feb 8, 2019 · Class II · Z-0974-2019: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
- Mar 28, 2017 · Class II · Z-1773-2017: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
- Mar 28, 2017 · Class II · Z-1774-2017: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
- Mar 28, 2017 · Class II · Z-1772-2017: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

## Indications for use
The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) 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 • etCO2 • Respiratory mechanics • Anesthetic agents • Neuromuscular transmission 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 Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

Source page: https://510kreport.com/device/K152407
Methodology: https://510kreport.com/methodology