510(k) · Cleared
ClearedSeatronics Family of Galvanic Oxygen Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seatronics Co. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Oct 16, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 16, 1995
- Review
- 91 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK953351 Seatronics Family of Galvanic Oxygen SensorsSeatronics Co. · 1995
- Descendant · cites it directly · 6 of its ownK972992 Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998
- Descendant · 2 generations on · 4 of its ownK082655 Envitec Medical Oxygen Senors, Models OOM101…Envitec-Wismar GmbH · 2008
- Descendant · 3 generations on · 3 of its ownK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · 4 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 5 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972992Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998 · cites it directly6descendants
- K082655Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH · 2008 · 2 generations on4descendants
- K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013 · 3 generations on3descendants
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 4 generations on1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953351 | Seatronics Family of Galvanic Oxygen Sensors | Seatronics Co. | 1995 | — |
| +1 | K972992 | Ceramatec Maxcell and Cag Galvanic Oxygen Sensors | Ceramatec, Inc. | 1998 | — |
| +2 | K082655 | Envitec Medical Oxygen Senors, Models OOM101… | Envitec-Wismar GmbH | 2008 | — |
| +3 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +4 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +5 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K972992 (Ceramatec, Inc., 1998) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K953351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953351: Seatronics Family of 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/K953351
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026