510(k) · Cleared
ClearedCeramatec Maxcell and Cag Galvanic Oxygen Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceramatec, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Mar 30, 1998 as substantially equivalent to K953351 (Seatronics Co., 1995) after a 230-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Mar 30, 1998
- Review
- 230 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953351 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953351 Seatronics Family of Galvanic Oxygen SensorsSeatronics Co. · 1995
- This deviceK972992 Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK082655 Envitec Medical Oxygen Senors, Models OOM101…Envitec-Wismar GmbH · 2008
- Descendant · 2 generations on · 3 of its ownK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK133064 Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip…Envitec-Wismar GmbH · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082655Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH · 2008 · cites it directly4descendants
- K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013 · 2 generations on3descendants
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 3 generations on1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 4 generations on0descendants
- K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953351 | Seatronics Family of Galvanic Oxygen Sensors | Seatronics Co. | 1995 | — |
| 0 (this device) | K972992 | Ceramatec Maxcell and Cag Galvanic Oxygen Sensors | Ceramatec, Inc. | 1998 | — |
| +1 | K082655 | Envitec Medical Oxygen Senors, Models OOM101… | Envitec-Wismar GmbH | 2008 | — |
| +2 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +3 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +4 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
| +3 | K133064 | Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large… | Envitec-Wismar GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953351 | Seatronics Family of Galvanic Oxygen SensorsSummary page 7…keted Predicate Device: The legally marketed predicate device is Seatronics Company's family of.galvanic oxygen sensors. The predicate device was assigned 510(k) number K953351 and was declared substantially equivalent by FDA. Safety and Effectiveness: No differences in intended use or application of the… | 1995 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (148 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972992: Ceramatec Maxcell and Cag Galvanic Oxygen Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972992
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026