# K122290: Envitec Mysign O Oxygen Measuring Device

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Jan 23, 2013 after 177 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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 K935370 (1994). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040484: MAXO2+, Model a and AE, Maxtec, Inc. (2004) Summary page 1.
- K063488: MAXO2 CU, Maxtec, Inc. (2007) Summary page 1.
- K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106, Envitec-Wismar GmbH (2008) Summary page 1.

## Most influential descendants
- K183687: LifeWindow LW8 Lite (2019), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own
- K133064: Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31 (2014), 0 descendants of its own

## Indications for use
This oxygen measuring device MySign® 0 is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas. MySign® 0 can be used for monitoring the breathing gases dispensed by the following devices' Anaesthesia breathing systems Respiratory equipment Infant incubators Oxygen therapy systems The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.

Source page: https://510kreport.com/device/K122290
Methodology: https://510kreport.com/methodology