# K972992: Ceramatec Maxcell and Cag Galvanic Oxygen Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Ceramatec, Inc.
- Decided: Mar 30, 1998 after 230 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: 1 generation back to K953351 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953351: Seatronics Family of Galvanic Oxygen Sensors, Seatronics Co. (1995) Summary page 7.

## Most influential descendants
- K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (2008), 4 descendants of its own
- 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
Purpose: The purpose of the Ceramatec family of galvanic oxygen sensors is to be the oxygen-sensing component in a finished medical device that monitors oxygen concentration. Function: The Ceramatec galvanic oxygen sensors are used in finished medical device products such as oxygen monitors, oxygen analyzers, ventilators and humidifiers. Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored. Environment of Use: The Ceramatec family of galvanic oxygen sensors is used in finished medical devices (i.e., oxygen monitors, oxygen analyzers, ventilators, humidifiers, etc.) in patient environments whose temperatures range from 5 °C - 40 °C and from 5% - 95% relative humidity (non-condensing). Device Claims: The Ceramatec family of galvanic oxygen sensors consists of oxygen sensing components in finished medical devices that have the indication or claim of monitoring oxygen concentration in the patients’ breathing environment.

Source page: https://510kreport.com/device/K972992
Methodology: https://510kreport.com/methodology