510(k) · Cleared
ClearedEnvitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envitec-Wismar GmbH · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Nov 25, 2008 as substantially equivalent to K972992 (Ceramatec, Inc., 1998) after a 74-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 25, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953351 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953351 Seatronics Family of Galvanic Oxygen SensorsSeatronics Co. · 1995
- 1 generation backK972992 Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998
- This deviceK082655 Envitec Medical Oxygen Senors, Models OOM101…Envitec-Wismar GmbH · 2008
- Descendant · cites it directly · 3 of its ownK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · 2 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK133064 Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip…Envitec-Wismar GmbH · 2014
Most influential descendants
Showing 4 of 4 · See all- K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013 · cites it directly3descendants
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 2 generations on1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 3 generations on0descendants
- K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953351 | Seatronics Family of Galvanic Oxygen Sensors | Seatronics Co. | 1995 | — |
| −1 | K972992 | Ceramatec Maxcell and Cag Galvanic Oxygen Sensors | Ceramatec, Inc. | 1998 | — |
| 0 (this device) | K082655 | Envitec Medical Oxygen Senors, Models OOM101… | Envitec-Wismar GmbH | 2008 | — |
| +1 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +2 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +3 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K972992 | Ceramatec Maxcell and Cag Galvanic Oxygen SensorsSummary page 1…II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K972992 Ceramatec MAXCELL and Ceramatek (Maxtec, Inc.) CAG Galvanic Oxygen Sensors Rea… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122290 | Envitec Mysign O Oxygen Measuring Device | 2013 | 3 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122290 (Envitec-Wismar GmbH, 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K972992.
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. 2008, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082655
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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