# K052119: Teslaguard, Model Eft G04

- Pathway: 510(k) (Traditional)
- Applicant: Mammendorfer Institute For Physics & Medicine GmbH
- Decided: Jan 3, 2006 after 152 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844187 (1985). 13 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033600: Infinity Gammaxl, Draeger Medical Systems, Inc. (2003) Summary page 2.
- K030313: Siemens Infinity SC 6002XL Modifications, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.
- K990563: Siemens SC 8000 Bedside Monitor with Advanced Communication Option, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K983632: Siemens SC 8000 Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K017016: Infinity Gamma XL. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K071802: Tesla Guard, Model Eft G04 (2007), 5 descendants of its own
- K142032: Mri Patient Monitoring System Tesla M3 (2015), 4 descendants of its own
- K172200: 3880 MRI Patient Monitoring System (2017), 2 descendants of its own
- K180903: 3880 MRI Patient Monitoring System (2019), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own

## Indications for use
The TeslaGuard® Patient Monitor is capable of monitoring: * SpO2 (Arterial Oxygen Saturation) * ECG (3-Lead) * IBP (Invasive Blood Pressure) * NIBP (Non-invasive Blood Pressure) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits. The device is intended to be used in the 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 device is intended for use in the Adult, Pediatric and Neonatal populations. MRI Compatibility Statement: The TeslaGuard® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.

Source page: https://510kreport.com/device/K052119
Methodology: https://510kreport.com/methodology