# K133064: Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: May 2, 2014 after 217 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: 6 generations back to K935370 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070193: Envitec Oxipen Pulse Oximeter and Accessories, Envitec-Wismar GmbH (2007) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K122290: Envitec Mysign O Oxygen Measuring Device, Envitec-Wismar GmbH (2013) Summary page 1.

## Indications for use
MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SP02) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

Source page: https://510kreport.com/device/K133064
Methodology: https://510kreport.com/methodology