# K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Nov 25, 2008 after 74 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: 2 generations back to K953351 (1995). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972992: Ceramatec Maxcell and Cag Galvanic Oxygen Sensors, Ceramatec, Inc. (1998) Summary page 1.

## Most influential descendants
- K122290: Envitec Mysign O Oxygen Measuring Device (2013), 3 descendants of its own
- 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
The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K082655
Methodology: https://510kreport.com/methodology