# K051658: Infinity Alpha

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 16, 2005 after 148 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: 8 generations back to K923682 (1992). 34 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 67 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.
- (no number) Infinity Delta series monitors: named in the summary without a submission number

## Most influential descendants
- K061379: Infinity Telesmart Telemetry System (2007), 26 descendants of its own
- K130711: Infinity Centralstation with Infinity M300 (2013), 25 descendants of its own
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 descendants of its own
- K151860: Infinity CentralStation Wide (2015), 23 descendants of its own
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own

## Indications for use
This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis. Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population. MRI Compatibility Statement: The Infinity Alpha is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K051658
Methodology: https://510kreport.com/methodology