# K050018: Teslaoxysat, Model Efoxysate

- Pathway: 510(k) (Traditional)
- Applicant: Mammendorfer Institute For Physics & Medicine GmbH
- Decided: Jul 1, 2005 after 178 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993555 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993555: Masimo Set/Quartz 2500 Pulse Oximeter and Accessories, Masimo Corp. (1999) Summary page 2.

## Indications for use
The TeslaOxySat Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 ) and pulse rate. The pulse oximeter is indicated for use with adult, pediatric, and neonatal patients. The TeslaOxySat PulseOximeter is designed for use in an MRI-environment at a maximum magnetic field strength of 2OmT.

Source page: https://510kreport.com/device/K050018
Methodology: https://510kreport.com/methodology